Device including RF source of energy and vacuum system

ABSTRACT

A method of a soft tissue treatment comprises placing an applicator adjacent to a surface of a body part, the applicator including at least one electrode, providing a fastening mechanism fixing the applicator in contact with the body part, providing a radiofrequency energy by the at least one electrode causing a heating of the soft tissue, providing an electric current to the soft tissue by the at least one electrode causing a muscle contraction, and controlling heating of the soft tissue by the radiofrequency energy and parameters of the electric current provided by the at least one electrode via a control unit, wherein an energy flux density of the radiofrequency energy is in a range of 0.01 mW·mm −2  to 10 W·mm −2  and a frequency of the radiofrequency energy is in a range of 0.1 MHz to 25 GHz, and wherein the body part comprises a face or a chin.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation in part of U.S. patent applicationSer. No. 16/194,800, filed Nov. 19, 2018, which is acontinuation-in-part of U.S. patent application Ser. No. 15/584,747filed May 2, 2017, now issued as U.S. Pat. No. 10,195,453 on Feb. 5,2019, which claims priority to U.S. Provisional Patent Application Nos.62/333,666, filed May 9, 2016; 62/331,060, filed May 3, 2016;62/331,088, filed May 3, 2016; 62/331,072, filed May 3, 2016;62/351,156, filed Jun. 16, 2016; 62/358,417, filed Jul. 5, 2016;62/375,796, filed Aug. 16, 2016, 62/340,398, filed May 23, 2016, and62/587,716 filed Nov. 17, 2017. This application also claims priority toU.S. Provisional Patent Application No. 63/019,619. All the listedapplications are incorporated herein by reference in their entireties.

FIELD OF THE INVENTION

This invention relates to noninvasive, aesthetic, automatedradio-frequency (RF) treatment devices and methods for treating softtissue using an RF electrode and a vacuum system.

BACKGROUND OF THE INVENTION

Soft tissue includes skin, muscle, fat, connective tissue (e.g. collagenfibers), nervous tissue (e.g. neurons, motor neuron and neuromuscularjunction), cartilage, veins, artery, body fluids (e.g. blood, lymphand/or other body liquids) and other soft structures.

Human skin is composed of three basic elements: the epidermis, thedermis and the hypodermis or so called sub cutis. The dermis consists ofcollagen, elastic tissue and reticular fibers. The hypodermis is thelowest layer (structure) of skin and contains hair follicle roots,lymphatic vessels, collagen tissue, nerves and also subcutaneous fatforming an adipose tissue.

Adipose tissue is formed by aggregation mostly of adipose cells mostlycontaining stored fats as triglycerides. Triglycerides are esters ofthree fatty acid chains and the alcohol glycerol (fat). Most adiposetissue accumulations result from fat primarily from food, when energyintake derived from food exceeds daily energy needs. This may result inan increase in fat cell size or fat cell number or both. Mature fatcells are very large, ranging up to 40 microns in diameter andcontaining as much as 95% lipid (fat) by volume. The subcutaneousadipose tissue layer may be thin (about 1 cm or less) in humans ofslight or moderate body type. It is possible to distinguish differenttypes of adipose tissue. Adipose tissue may mean visceral (fat) adiposetissue located adjacent to internal organs, subcutaneous adipose tissuelocated beneath the skin but above skeletal muscle and/or adipose tissuelocated between the muscle fibers.

Excess adipose tissue may be perceived as aesthetically undesirable.Excess adipose tissue may lead to health complications.

Dieting and exercise may result in reduction of adipose tissue andweight loss. However, the reduction in adipose tissue volume occursrather unpredictably from all anatomical areas. This can leave the areasintended for reduction (e.g. the abdomen) largely unaffected, even aftersignificant body weight loss. Dieting and exercise may also causediscomfort, physical and psychic stress. Various invasive andnon-invasive methods have been developed to remove unwanted subcutaneousfat from specific areas of the body.

The main invasive method is surgical-assisted liposuction, whereselected volumes of adipose tissue are mechanically aspirated out of thepatient at desired anatomical sites of the body. However, liposuctionprocedures are invasive and can be painful and traumatic, with manyundesirable side effects and risks. Lipodissolve is another invasiveprocedure involving a series of drug injections intended to dissolve andpermanently remove small pockets of fat from various parts of the body.It is also known as mesotherapy, lipozap, lipotherapy or injectionlipolysis. Lipodissolve has many disadvantages and risks also, to theextent that various medical associations have issued health warningsagainst using it.

The non-invasive methods concentrate on the acceleration of thelipolysis as the natural process of the fat reduction. This can beachieved in several ways. One of them is application of pharmaceuticalsaccelerating the lipolysis. However, when applied topically they tendonly to affect the outermost layers of the skin, rarely penetrating tothe sub dermal vascular plexus. Another method uses radio frequency orultrasound energy focused on adipose tissue to cause cell destructionand cell death. These methods tend to damage the melanocyte in theepidermis. The hyper thermic temperatures destroy the target tissues andleave the body to remove the dead cellular and other debris.Non-invasive heating techniques have also been used. These non-invasivemethods have certain disadvantages as well (e.g. inhomogeneous softtissue heating, creating of hot spots, panniculitis etc.), and have beenused with varying degrees of success.

Accordingly, there is need for improved methods and systems forsubcutaneous treatments. There is also a need to improve the energy flowthrough the tissue of treated patient to reduce or eliminate risks ofoverheating of non-target soft tissue, improve homogeneity of heatingdesired layer of soft tissue in order to prevent hot spots. Heating ofsoft tissue by an external source of energy may cause other undesiredeffect and health complications e.g. non-controlled heating oroverheating of the soft tissue that is also needed to improve.

SUMMARY OF THE INVENTION

Apparatus and methods provide RF (radio-frequency) treatment withapplied negative pressure (pressure lower than atmospheric pressure).

Parameters of the soft tissue may greatly influence transfer of a(radio-frequency) treatment RF energy into the soft tissue and atreatment result. Parameters of the soft tissue which may be influencedinclude e.g. polarity of the soft tissue, dielectric constant, specificheat capacity, coefficient of thermal diffusion and/or other parametersof the soft tissue may be influenced. Factors that may influenceparameters of the soft tissue may include e.g.: temperature, bodyliquids flow and/or other mechanisms; in the treated soft tissue.Varying of RF signal parameters may enhance RF signal penetration and/ortargeting to specific soft tissue structure in order to achieve desiredtreatment results. RF signal parameters include, for example, frequency,polarization of RF waves, ratio between magnetic and electric componentof RF waves, output power, pulse intensity, pulse duration, sequence ofpulses, shape of pulses, envelope of provided signal, duration ofcontinual radiation, distance between the electrode, orientation of theelectrode, surface of the electrode, shape of the electrode, shape ofelectromagnetic field, homogeneity of electromagnetic field, fluxdensity of provided RF energy and/or others. Enhancing of treatmentresults may be also provided combination of RF signal of one frequencywith RF signal of different frequency and/or by combination of treatmentRF energy with another type of treatment energy like e.g. light,magnetic field, electric current, plasma, heating/cooling, mechanicalwaves (ultrasound, shock wave . . . ) and/or any type of massage. RFtreatment result may be also improved by medication to patient before,during and/or after treatment session.

Knowing the dielectric constant (mainly its complex part) of specificsoft tissue structure may be important when providing treatment using anelectromagnetic field e.g. RF energy. The dielectric constant behaves asa parameter with real and imaginary parts that depend on severalphysical quantities. The dielectric constant of specific soft tissuestructure may depend on the frequency of the RF signal, the ratiobetween electric and magnetic components of the RF signal, the directionof spreading of the RF wave, the temperature of the environment where RFwave spreading occurs, distance and/or other factors.

The electromagnetic energy may be ionizing energy (e.g. gamma radiationand/or X-rays), light (e.g. ultraviolet, visible and/or infrared light),terahertz energy, microwave energy and/or radiofrequency energy.Electromagnetic energy may include coherent and/or non-coherent energy.

Tissue with a low complex dielectric constant is heated more quicklythan a tissue with a high complex dielectric constant during capacitiveRF energy transfer in frequency ranges up to 0.5 MHz or more preferablyup to 10 MHz. For example, bone tissue and adipose tissue have a lowdielectric constant in comparison to muscle. Absorbed power of adiposetissue (P_(a)) and muscle tissue (P_(m)) is different. The ratio(P_(a)/P_(m)) is large, as a consequence of relatively smallconductivity ratio (δa/δm) and dominantly a large permittivity ratio(Iε_(m)*I²/Iε_(a)*I²), such that a relatively large absorption occurs inthe adipose tissue.

Increasing temperature in the soft tissue may have other positiveeffects. Hyperthermia may be used in order to vary physical parametersof the soft tissue, to improve regeneration of injured muscles,cartilage, other soft tissue deficiencies, to improve blood flow, lymphflow, remove degeneration caused by aging, or excrescent of adipose.

The apparatus may provide heating of the soft tissue by thermaldiffusion from an applicator to the patient's body and/or heat bydelivered one or more other treatment energy sources e.g.: thedielectric loss RF treatment energy by an RF treatment energy source.

Changing temperature of the soft tissue before, during and/or after thetreatment may influence pain receptors, soft tissue laxity, dielectricproperties of soft tissue, improve homogeneity of distributed energydelivered to the soft tissue by the treatment energy source (e.g.prevent hot spots), stimulate fat metabolism, prevent edge effects,and/or create temperature differences in the soft tissue. A temperatureof the soft tissue target area during the treatment may be selectivelyadjusted with or without changing temperature of adjacent areas, inorder to improve comfort and/or effectiveness of the treatment.

Various aesthetic skin and/or body treatment effects may be provided bythe present methods and devices including: anti-aging (e.g.: wrinklereduction, skin tightening, hydrating the skin, skin rejuvenation, skinviability, removing of pigment deficiencies and/or pigmentationcorrection); skin disease (e.g.: rashes, lupus, fungal diseases, surfaceantimicrobial treatment procedure, hypothermia, hyperemia); soft tissuerelaxation (e.g.: muscle and/or other soft tissue layers relaxation);body shaping (e.g.: fat removing, removing of unwanted soft tissuelaxity, removing of cellulite, building muscle mass and strength,accelerating fat metabolism of a cells, restructuring of the connectivetissue; increase in the number of fibroblasts, enhancement of fibroblastproliferation, by neocolagenesis and/or elastogenesis); and/or othersoft tissue deficiencies (e.g.: by accelerating body metabolism,stimulating the lymphatic circulation), circumferential reductioninfluence membrane transport of a cell, a proliferation of chondrocytesin the cartilages, increase in blood perfusion, blood flow and venousreturn, wound healing, disinfection of the patient surface and/orrelieving of a patient's body pain).

The light therapy devices and methods of the present invention may beused for physical treatment of various tissue problems, including butnot limited to Achilles tendonitis, ankle distortion, anterior tibialsyndrome, arthritis of the hand, arthrosis, bursitits, carpal tunnelsyndrome, cervical pain, dorsalgia, epicondylitis, facial nerveparalysis, herpes labialis, hip joint arthrosis, impingement syndrome,frozen shoulders, knee arthrosis, knee distortion, lumbosacral pain,muscle relaxation, nerve repair, onychomycosis, Osgood-Schlattersyndrome, pain relief, painful shoulders, patellar tendinopathy, plantarfasciitis, heel spurs, tarsal tunnel syndrome, tendinopagny, ortendovaginitis. Other applications may include treatment of open wounds,dry eyes and general treatment of the eye.

Some embodiments of devices and methods of the present invention mayalso be used for aesthetic and cosmetic methods coupled to tissueproblems, e.g. hair epilation and/or depilation, hair removal, hairregrowth stimulation, reduction of adipose tissue, hyperhidrosis,cellulite treatment, elastin remodeling, elimination of stratum corneum,collagen remodeling, acne treatment, skin rejuvenation, skin tightening,wrinkle removal, stretch mark removal, tattoo removal, teeth whitening,treatment of tooth decay, treatment of rhinitis, or circumferentialreduction. Embodiments of the present invention may be also used totreat vulvar laxity and/or hemorrhoids. Some embodiments are alsocapable of at least partial removal of rosacea, dermatitis, eczema, caféau lait spots, apthous stomatitis, halitosis, birthmarks, port-winestains, pigment stains, skin tumors, scar treatment, or scarelimination. Some embodiments of the present invention may also be usedfor general surgery, dentistry, stomatology, or body modification, e.g.scarification.

Treated parts of a human body may in some embodiments include, but arenot limited to, the face, neck, nose, mouth, arms, hands, torso, back,love handles, abdomen, limbs, legs, head, buttocks, feet and/or thighs.

Predefined treatment therapy methods may be manually performed by anoperator and/or automatically performed by a controlling mechanism (e.g.control unit) or changed during the treatment based on feedbackparameters, based on the treatment protocol and/or based on previoustreatment or measurement. Multiple treatment energy sources may becombined to provide a synergic effect on human tissue. This improveseffectiveness of the treatment and/or reduces time needed for thetreatment. It may also improve safety of the treatment e.g. stimulationof soft tissue by massage improves blood and lymph stimulation which incombination with an RF field provides improves removal of treated fatcells (prevention of panniculitis), improves homogeneity of deliveredenergy in to the soft tissue, targeting of delivered energy to the softtissue, reduces pain during the therapy and/or a decreases the influenceof edge effects and overheating of a part of the soft tissue due toenhanced body liquid circulation.

Another example of synergic effects may be utilization of plasma (e.g.non-thermal plasma), where an RF electrode may regulate plasma, help tocreate plasma and/or adjust some parameters of plasma. Severaltreatments in combination may provide better transfer of the energy to aspecific layer of the soft tissue; e.g. preheating, massage of thepatient skin surface to accelerate blood flow that increases the complexdielectric constant of the surface and increases penetration of suchlayer by RF waves.

The apparatus may operate without any operator which saves time andreduces costs of the treatment. The apparatus may automatically controlparameters of treatment energy and/or other parameters of the deviceassociated with treatment. One operator may supervise more than onetreated patient. Self-operated devices may prevent mistakes during thetreatment caused by human factors. A self-operated device may also havea better response to changed conditions of the treatment and/or mayprovide more homogenous and precise treatment which improves results andsafety of the treatment. A computer may have a better response tochanged conditions because it can react faster than 0.001 s, whereashuman response on occurrences like moving of the patient, or structuralchanges in the soft tissue is at least 0.5 s. Another benefit ofself-operated devices may be that the operator does not have to be asskilled as when using manual device.

The applicator may be adjacent to a patient surface and it may beflexible and of arbitrary size and shape. This characteristic helps toprovide optimal energy transfer from an applicator to the patient softtissue. More perfect contact with the patient surface may decrease orprevent the edge effect backscattering of delivered energy (which mayimprove focusing of the delivered energy) and/or provides optimalconditions for collecting feedback information. Direct contact with thepatient surface may also be used for accurate and fast regulation ofpatient surface temperature.

According to this document, diabetes symptoms include a blood glucosevalue above the normal limit.

GLOSSARY

It is to be understood that the figures and descriptions of the presentinvention have been simplified to illustrate elements that are relevantfor a clear understanding of the present invention, while eliminating,for the purpose of clarity, many other elements found in related systemsand methods. Those of ordinary skill in the art may recognize that otherelements and/or steps are desirable and/or required in implementing thepresent invention. However, because such elements and steps are wellknown in the art, and because they do not facilitate a betterunderstanding of the present invention, a discussion of such elementsand steps is not provided herein. The disclosure herein is directed toall such variations and modifications to such elements and methods knownto those skilled in the art.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this invention belongs. Although any methods andmaterials similar or equivalent to those described herein can be used inthe practice or testing of the present invention, the preferred methodsand materials are described.

As used herein, each of the following terms has the meaning associatedwith it in this section.

The articles “a” and “an” are used herein to refer to one or to morethan one (i.e., to at least one) of the grammatical object of thearticle. By way of example, “an element” means one element or more thanone element.

“About” as used herein when referring to a measurable value such as anamount, a temporal duration, and the like, is meant to encompassvariations of ±20%, ±10%, ±5%, ±1%, and ±0.1% from the specified value,as such variations are appropriate.

Throughout this disclosure, various aspects of the invention can bepresented in a range format. It should be understood that thedescription in range format is merely for convenience and brevity andshould not be construed as an inflexible limitation on the scope of theinvention. Accordingly, the description of a range should be consideredto have specifically disclosed all the possible subranges as well asindividual numerical values within that range. For example, descriptionof a range such as from 1 to 6 should be considered to have specificallydisclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numberswithin that range, for example, 1, 2, 2.7, 3, 4, 5, 5.3, 6 and any wholeand partial increments therebetween. This applies regardless of thebreadth of the range.

Soft tissue structure or specific soft tissue part is a part of the softtissue that exhibits the same or nearly the same physical parametersand/or structural characteristic (e.g. water content, content andstructure of collagen, protein content, stiffness etc). Examples ofdifferent specific soft tissue structures are: collagen fibers, veins,adipose tissue, keratinocytes in epidermis, nerves, muscle, cartilageand/or other soft tissue structures.

Treatment protocol is a software protocol that defines treatmentparameters, guides treatment process of one or more treatment energysources and defines parameters of provided treatment energy. At leastpart of the treatment protocol may be preprogramed in a control unit,other controlling mechanism with CPU, or may be used from an externaldevice (e.g.: downloaded from a network or recorded from an externaldevice). Treatment protocol may be design, selected and/or adjusted byan operator and/or by software in a control unit, external device and/orby other controlling mechanism based on feedback information and/orprevious experience. Two or more treatment protocols or at least part oftwo or more treatment protocols may be combined together and create newone treatment protocol.

An external device is a device including hardware and software providedseparately from the treatment device. An external device may be e.g.: acomputer, smartphone, tablet, USB flash disc, or other equivalentdevice. The external device communicates with a control unit and/or maycommunicate with other controlling mechanisms.

A treatment energy source is a hardware part of the device that mayprovide treatment energy in order to provide treatment effects.

Active surface of the applicator is area providing treatment therapyand/or more therapies.

A treatment pattern creates pattern by switching between applicatorsand/or treatment elements providing one or more types of the therapyacross the patient surface. A treatment pattern may include differenttypes of switching sequences, and also include at least one of: aspecific treatment therapy is applied; a selection of applicators and/ortreatment elements applying specific treatments; timing of the appliedtherapy; the distance between at least two applicators; duration of thetreatment therapy applied; body location where the treatment therapyapplied; cycle of applying one or more specific treatment therapies.

A treatment pattern may provide information about applying one or moretypes of the treatment therapies and their manner (e.g.: simultaneous,sequential and/or applying of one or more treatment therapies with someoverlay). A treatment pattern may simulate moving of the one or moreapplicators guided by an operator by switching between applicatorsand/or treatment elements of one or more applicators and/or one or moretreatment therapies. Simulated moves may be circular, zig-zag, spiral,other geometrical pattern, scanning and/or other pattern that may becreated by moving the applicator guided by operator. A treatment patternmay also be used for scanning of the patient soft tissue.

A hardware pattern is a composition of the device and placement of theparts of the device. A hardware pattern also includes placement of theapplicators which is in some embodiments not limited (e.g.: in thesupporting matrix, on the patient surface etc.), placement of thetreatment unit, and/or other devices adjacent/at working distance to thesoft tissue (which includes direct, indirect or no contact).

Treatment energy is energy provided to the patient's body in order tocause treatment effects. Treatment energy provided by the device may befocused or unfocused, selective or non-selective. Applied treatmentenergy may be: RF, light, electric current, plasma, continual and/ortime varying magnetic field, mechanical wave e.g. like acoustic wave(including ultrasound), shock wave, mechanical friction of patient'sskin surface, heating, cooling, or applied pressure to the patient softtissue.

In this document RF signal, RF waves and/or RF energy are in relationwith radiofrequency field produced by RF treatment energy source.

Treatment effect is an effect caused by treatment energy in thepatient's body. Treatment effect may also be influenced and/or caused byapplied active substances described below. Treatment effect causesintended metabolic and/or structural changes in the patient's softtissue and/or cells. Treatment energy may be targeted to cause treatmenteffect in a bone tissue. The device may provide treatment effects:treating and/or suppressing diabetes symptoms, wrinkle reduction, skintightening, hydration of the skin, skin rejuvenation, skin viability,removing of pigment deficiencies, slowing of soft tissue aging process,treating of rashes, treating of lupus, treating of fungal diseases,surface antimicrobial treatment procedure, hypothermia, hyperemia, softtissue relaxation e.g.: muscle, sinew and/or other soft tissue layersrelaxation; body shaping e.g.: adipose cell volume downsizing, adiposecell removing, removing of unwanted soft tissue laxity, removing ofcellulite, building muscle mass and strength, accelerating fatmetabolism of a cells, restructuring of the connective tissue; increasein the number of fibroblasts, enhancement of fibroblast proliferation,neocollagenesis and/or elastogenesis; acceleration of body metabolism,stimulation of blood and lymphatic circulation, circumferentialreduction influence membrane transport of a cell, a proliferation ofchondrocytes in the cartilages, increase in blood perfusion, blood flowand venous return, wound healing, restore nerve functionality, influencecell proliferation, disinfection of the patient surface and/or relievingof a patient body pain, enhancing of bone density.

Treatment parameters may be any parameters influencing the treatment ofthe patient. Treatment parameters mainly determine type and parametersof the treatment energy. The term “treatment parameters” refers to theconfiguration parameters of a treatment device of the present invention,including but not limited to value of applied pressure, switching on/offsequence of specific treatment energy source or sources, the energyoutput, treatment duration, energy spot size and shape, scanning speed,direction of the movement of the energy spot, the treatment pattern, thewavelength or wavelengths of the energy, the frequency of providedenergy, the distance between the subject tissue and the scanning unit orsource of energy, target area or part of the soft tissue, pulseduration, pulse sequence, frequency of delivered energy by treatmentenergy source, amount of delivered radiation, energy flux density,duration of delivered treatment energy, timing of applied treatmentenergies, temperature value of the soft tissue and/or part of thedevice, focusing parameters of delivered treatment energy as focal spotvolume, depth, electric voltage on the treatment energy source,intensity of provided magnetic field and/or other parameters, distancee.g. between treatment energy source and patient's skin surface(epidermis) and/or other parameters.

A shape adaptive material adapts its shape and volume as influenced byexternal forces

An elastic material adapts its shape but not volume. The elasticmaterial may stretch or deform to adapt to external forces.

Target area/tissue is part of the soft tissue targeted by focused orunfocused treatment energy to provide treatment effect.

Discomfort temperature is the temperature of at least part of thepatient's soft tissue that becomes painful and/or highly uncomfortableaccording the patient's subjective feeling.

Comfortable temperature is the temperature of at least part of thepatient's soft tissue that is tolerable for the patient accordingsubjective patient's filling, treatment protocol and/or feedbackinformation from specific sensors.

Bolus is a special embodiment of dielectric material with a cavityinside located between patient surface and the treatment source ofenergy. The cavity of the bolus may be filled with fluid that may be anytype of gas, liquid, gel, suspension and/or mixture. Fluid may also flowthrough the bolus and may regulate its temperature and/or dielectricparameters.

RF electrode or electrode in this text has the same meaning. RFelectrode is treatment energy source that may provide RF treatmentenergy or electrotherapy.

Contact part of the applicator is lower part of the applicator locatedin proximity to treatment area. According one embodiment described belowcontact part of the applicator may be dielectric material which is indirect contact with the patient's skin surface (e.g. see part 401 a FIG.4) or surface of the treatment energy source. Vacuum edge is notconsidered as contact part of the applicator.

The term “proximity” refers to direct contact and/or spaced by air gapand/or any other material with a dielectric constant higher than 1 (e.g.a gel layer).

RF signal and RF energy have the same meaning in this text.

The term “tissue problems” refers to any tissue problem that mightbenefit from the treatments of the present invention, including but notlimited to an open wound, excess hair, excess adipose tissue, wrinkles,sagging skin, excess sweat, scars, acne, stretch marks, tattoos,biofilms of bacteria, viruses, enlargement, rosacea, dermatitis, eczema,café au lait spots, calcium deposits, birthmarks, port-wine stains,pigment stains, skin tumors, apthous stomatitis, halitosis, herpessimplex, ulcers or other skin diseases classified by the WHO.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic diagram of a treatment device

FIG. 2A and FIG. 2B illustrates influence of patient's surfaceheating/cooling to homogeneity of provided treatment

FIG. 3 illustrates a heating sequence of the patient's surface

FIG. 4 illustrates an applicator embodiment.

FIG. 5 is a schematic diagram of an RF-regulating system

FIG. 6 illustrates a valve embodiment

FIG. 7 illustrates shape change of a vacuum guiding part that mayregulate vacuum level

FIG. 8 illustrates deformation of a vacuum guiding part that mayregulate vacuum level under the applicator

FIG. 9 illustrates high-frequency connector

FIG. 10 is a diagram of an exemplary device

FIG. 11A is a schematic of an exemplary handheld applicator

FIG. 11B is another example of a handheld applicator

FIG. 12A is an example of a handheld applicator disconnected from ascanning unit

FIG. 12B is an example of a handheld applicator connected to a scanningunit

FIG. 13 shows examples of treatment patterns

FIG. 14A is an example of a treatment area and treatment pattern

FIG. 14B is another example of a treatment area and treatment pattern

FIG. 15A is an example of energy distribution

FIG. 15B is another example of energy distribution

FIG. 15C is another example of energy distribution

FIG. 16A is an example of device using negative pressure

FIG. 16B is another example of device using negative pressure

FIG. 17 is schematic representation of cooperation multiple applicatorsacross the patient body.

FIG. 18 is a schematic diagram of the present apparatus or system.

FIG. 19 is a partial perspective view of an embodiment of the beltproviding hardware pattern.

FIG. 20 is schematic representation of one embodiment device modularity

FIG. 21 is a schematic diagram of treatment elements in the applicator.

FIG. 22 is schematic diagram of arrangement of electrodes into a matrix.

FIG. 23a is a plot of electromagnetic pulse sequences.

FIG. 23b is an example of frequency modulation within a pulse.

FIG. 23c is an example of amplitude modulation within a pulse.

FIG. 23d shows one of the possible modifications of leading and trailingedges of a pulse envelope.

FIG. 24 is a plot of one example of pulsed cooling alternating withelectromagnetic pulses, showing also the evolution in time oftemperatures at surface and at depth.

FIG. 25 is an example of preheating followed by pulses of higher poweralternated with pulses of lower power.

FIG. 26 illustrates an amplitude modulated wave having a sine envelope.

FIG. 27 illustrates a frequency modulated wave.

FIG. 28a shows an example of preheating with higher power level followedby continuous mode heating with lower power level.

FIG. 28b shows an example of preheating with higher power level followedby pulsed mode heating with lower power level.

FIG. 29 is a schematic diagram of a treatment system.

DETAILED DESCRIPTION OF THE INVENTION

The device and method provide treatment of the soft tissue by applyingat least one treatment energy source. Treatment may be based onselective capacitive and/or targeted inductive heating of the targetsoft tissue. Target tissue may be adipose tissue, collagen fibers and/orother part of the soft tissue where treatment energy is provided inorder to provide a treatment effect. Treatment may also restore andaccelerate cell metabolism, improve lymphatic circulation, bloodcirculation and/or blood supply of dermis.

The device may be used to remove and/or reduce: wrinkles, spider veins,volume of fat cells, number of fat cells, cellulite, redness of skin,pigment inhomogeneity, lupus symptoms, scars, acne and/or other bodyimperfections.

The device may also be used to rejuvenate skin, improve skin elasticity,skin hydration, circumferential reduction, body contouring and/or othertreatment effect described in glossary.

According to one embodiment the device may treat and/or suppressdiabetes symptoms.

The method and device may provide one or more treatment energy sourcesin order to provide treatment to the patient e.g.: vacuum (constant orvariable pressure value under the applicator), mechanical wave energy(ultrasound wave energy, shock wave energy), light energy, plasma,thermal energy, electric current, magnetic field and/or preferablyradio-frequency treatment energy (RF). Different treatment energyproduced by treatment energy sources and different treatment effect maybe used individually and/or may be combined. Different treatment energymay be combined in one or more treatment energy sources in one or moreapplicators. Such an example may be an RF electrode as a first treatmentenergy source and a piezo-element as a second treatment energy sourcewherein both treatment energy sources may be placed in one applicator orseparate applicators.

According to one preferred embodiment, an RF energy source may be usedin combination with treatment energy source improving blood and/or lymphflow (e.g. applied vacuum, mechanical wave, source of energy providingmassage and/or muscle contracting stimulation) in order to improve heatredistribution produced by RF energy source in the soft tissue.

Another preferred combination may be RF treatment energy source andtempered RF electrode and/or applicator's contacting part to highertemperature than 37° C. The RF energy source in combination with heatingenergy source prevent leaking of heat delivered to patient's body by RFenergy source. Treatment effect may be collagen fibers remodeling,induced neocollagenesis and elastogenesis that improve wrinkle reductionand skin laxity.

The device may treat any part of the patient body e.g. face, doublechin, thighs, saddlebags, buttocks, abdomen, region of bra fat, arm,etc. The specific treatment energy as electric and/or magnetic musclestimulation may be targeted to at least part of specific muscle group tostimulate at least part of one muscle fiber. Muscle groups may be majormuscle group e.g.: upper back, infraspinatus, deltoids, biceps, triceps,forearms, chest muscle, middle back, lower back, side abs, rectusabdominis, gluteus maximus, hamstring group, quadriceps, tibialisanterior, calf; and/or deep muscle e.g.: pelvic floor muscles, psoasmajor muscle.

As shown in FIG. 1, the device may include a user interface 101, a powersupply 102, a control unit 103, an applicator 104 and other devicehardware parts.

User interface 101 may be used for switching the device on/off,selection of a treatment protocol, setting treatment parameters (beforeand/or during the treatment) and/or as an information panel. Userinterface 101 may be connected to control unit 103 and/or control unit103 may be part of the user interface 101. User interface 101 may beoperated by touch display, other type of display, one or more buttons,joystick, by other control element and/or combination of thereof.Optionally user interface 101 may be also external device connected to acontrol unit wirelessly, by wire and/or optical fiber. Such externaldevice may be e.g. a smartphone, computer and/or other device.

A power supply 102 may interact with control unit 103, energy generatingunit 105, temperature control system 106, vacuum control system 107,other controlling mechanisms, treatment energy sources e.g. treatmentenergy source 108, vacuum system 109 and/or temperature regulatingelement 110; and/or other parts with need of power supply.

Control unit 103 may comprise an energy generating unit 105, atemperature regulating system 106 and a vacuum control system 107. Theenergy generating unit 105, the temperature regulating system 106 andthe vacuum control system 107 may be part of the control unit 103 or maybe as individual controlling mechanisms that may communicate withcontrol unit 103, with each other and/or with other controllingmechanism and/or sensor. The energy generating unit 105, the temperatureregulating system 106 and the vacuum control system 107 may consist ofsoftware part, hardware part and/or combination of software part withhardware parts. The controlling mechanism may be able to change specificparameters of delivered treatment energy to the patient body. Theparameters may include frequency produced by the treatment energysource, pressure under the applicator, position of the applicator,output power of treatment energy source, pulse mode, temperature of theapplicator's contact part with the patient, patient's temperature and/orothers. Each of controlling mechanisms may change specific parametersaccording to information sent by control unit 103, other controllingmechanisms, information sent from user interface 101, based on feedbackinformation from at least one sensor and/or automatically accordingtreatment protocol incorporated in controlling mechanism, control unit103, or user interface 101.

The applicator 104 may include at least one treatment energy source 108,vacuum system 109, temperature regulating element 110, sensor 111 and/orother parts. A heat exchanger 112 may be localized in or outside of theapplicator.

According another embodiment vacuum system 109, temperature regulatingelement 110 and/or sensor(s) 111 may be localized outside the applicator104 (e.g. in the mother cases).

Control unit 103 may be located in the mother case as described in U.S.Provisional Application No. 62/375,796 incorporated herein by referenceand/or in the applicator. Control unit 103 may comprise a separate ormerged temperature control system 106 guiding temperature adjusting ofthe patient's epidermis, dermis, hypodermis, adipose tissue and/ortemperature control system, energy generating unit, or vacuum controlsystem.

Temperature control system 106 may provide guiding of at least onetemperature regulating element 110 that regulates temperature ofpatient's soft tissue and/or any part of the device e.g.: the electrode,heat transmitter included in the heat exchanger 112, temperature of thematerial between treatment energy source and patient's body and/or anyother part of the device.

Temperature regulating element 110 may include a passive temperatureregulating element, active temperature regulating element or theircombination.

A passive temperature regulating element may be an element changingtemperature without need of input power supply e.g.: perforation of theapplicator may provide cooling of any device by spontaneous air flow,material with high thermal conductivity removing heat by thermaldiffusion between at least one part of the applicator and theenvironment spontaneously.

An active temperature regulating element may be an element changingtemperature using an input power supply. An active temperatureregulating system may be e.g.: heated or cooled fluid pumped to theapplicator or in its proximity in order to adjust electrode temperature,a thermoelectric member adjusting temperature of any device part by thePeltier-Seebeck effect, heating coils heated by electric current, anelement delivering sprayed coolant, ventilator and/or any othertemperature regulating system.

Temperature control system 106 may cooperate with one or more sensorsmonitoring and/or contributing to evaluate temperature of the softtissue and/or part of the device. Sensor or sensors contributing toevaluate temperature may not measure temperature as physical quantitybut may measure a different physical quantity influenced by temperatureand temperature may be calculated by using such influenced physicalquantity. E.g. impedance of the soft tissue may change with changedtemperature of such specific soft tissue part. Based on evolvingimpedance of the specific soft tissue part, temperature may becalculated by using a preprogramed correlation function.

Temperature may be controlled with regard to the temperature of thee.g.: RF electrode; heat transmitter (may be any kind of fluid e.g.:water, CO₂, etc.); dielectric material as described below; the patient'sepidermis, dermis, hypodermis, adipose tissue as visceral adipose tissueand/or subcutaneous adipose tissue.

Temperature control 106 system may adjust temperature of a heattransmitter in the heat exchanger 112 with gaseous or liquid heattransmitter.

The heat exchanger 112 and/or gaseous or liquid heat transmitter mayoptionally be omitted.

Heating/cooling of the patient's soft tissue (e.g.: epidermis, dermis,hypodermis and/or adipose tissue) may be provided by conduction based onthermal diffusion between the applicator and the patient's body and/orby radiation caused by e.g.: RF waves, acoustic waves, plasma, musclestimulation, friction, and/or other.

The device and method maintain optimal treatment temperature of thepatient's surface (epidermis) and/or contact part of the applicator inthe range of 28° C.-54° C. or 30° C.-50° C. or 35° C.-48° C. or 36°C.-45° C. or 36-41° C.

According to one embodiment contact part of the applicator may betempered in range of 35° C.-45° C. e.g. by liquid flowing through the RFelectrode, by resistive heating of the electrode and/or by othermechanism. The RF source of energy targeted to hypodermis and deeperdecrease adipose cells volume, adipose cells number and also heatsepidermis and dermis from the opposite side than tempered contact partof the applicator. As a result patient's epidermis and dermis is heatedfrom the both sides that cause homogenous heating across the volume ofepidermis and dermis with minimal energy losses and higher effectivenessof the device. Heating of epidermis and dermis maintained in range of35° C.-45° C. effect skin metabolism and collagen fibers that results inskin tightening, rejuvenation and/or wrinkle reduction.

In the present device and method the patient's epidermis may be heatedto the temperature mentioned above in order to prevent heat shock of thepatient's body. Any part of the applicator may be heated/cooled byitself and/or by temperature regulating element 110 and may regulatepatient's surface temperature.

According to one embodiment patient's surface may be heated and/orcooled by thermal conduction and/or radiation between a heater/cooler,RF electrode and the patient's and/or between heater/cooler, adielectric material and patient and/or between heater/cooler and patientsurface or skin. The dielectric material may be any dielectric and/orinsulating material with dielectric constant/relative permittivityhigher than 1 and located between the RF electrode and patient'ssurface. The dielectric material may be e.g.: bolus filed with anyfluid, textile layer, silicon active agent etc.

If a temperature difference between patient surface and treated lowerlayers of the patient's soft tissue (e.g. hypodermis, visceral adiposetissue) is too high the treatment may be uncomfortable and/or painful.For example if patient's epidermis is cooled to 25° C. and patient'sadipose tissue is heated to 48° C. then heat significantly and very fastdiffuses from heated adipose tissue into the cooled area of the skin andtreatment is inefficient, inhomogeneous and health risk may beincreased.

FIG. 2A and FIG. 2B are pictures from a thermo-camera that illustratessurface temperature after treatment provided by a bipolar RF source.FIG. 2A demonstrates treatment by two applicators (according to FIG. 6)where an electrode of each applicator was cooled below 25° C. FIG. 2Bdemonstrates treatment with the same applicators where electrode of eachapplicator was heated above 25° C. Cooled/heated electrodes according toFIG. 2A and FIG. 2B influenced temperature of the patient's epidermisand homogeneity of the treatment of hypodermis.

Heating the patient's surface to 25° C. or higher but lower than 43° C.(which is pain threshold) is very effective for improvement ofhomogeneity of the delivered RF treatment energy and energy distributionin the soft tissue. Heating the patient's surface also minimizes heatdiffusion from the heated soft tissue (e.g. adipose tissue), which mayimprove effectiveness and homogeneity of the treatment and also mayallow for shorter treatments Heating the patient's surface improvesblood flow in the skin which improves dispersion of the heat in the skinsurface, preventing creation of hot spots. Increased blood flow maylocally accelerate body metabolism and also accelerate removing ofdamaged and/or dead cells. Such effect may accelerate results and reducehealth risk. Increased blood flow may also improve selectivity of RFheating and filtering of unwanted/parasitic frequencies of the RFsignal.

Heating of the patient's epidermis shows positive influence to the skinrejuvenation, increase skin elasticity and improvement of skinimperfections (e.g. structural inhomogeneity, stiffness of the scar).Heating of the patient's surface, namely dermis, with a combination ofRF treatment, also improves results of cellulite removal and localacceleration of cell metabolism.

According to another embodiment cooling of the patient's epidermis below20° C. may be provided. When skin surface temperature is decreased below20° C. pain receptors may have lower sensitivity. With cooling of thepatient's surface, it is also possible to increase output power of thetreatment energy source 106 beyond the limit acceptable during treatmentwithout regulation of the patient's surface temperature. This methodrequires optimal adjusting of delivered treatment energy parameters.

Optimal treatment temperature of the treated adipose tissue may be inthe range of 38-60° C. or 41-47° C. or 42-45° C. The method and thedevice may be designed to provide many kinds of a treatment mostly basedon apoptotic, necrotic destruction of adipose tissue and/or increasingadipose metabolism (catabolism). Therefore the treatment leads toreducing number and/or volume of adipose cells. Another therapy may betargeted to soft tissue layer (e.g. dermis) in order to startneocollagenesis and/or elastogenesis (for e.g. wrinkle reduction,rejuvenation).

Heating of epidermis and/or other soft tissue structure (e.g. dermis,hypodermis, adipose tissue) may be provided continuously with continualheating or according to an arbitrary heating sequence until soft tissuetemperature reaches a predefined tissue temperature. During continualheating treatment energy source output may be variable but temperatureof the soft tissue rises until a predefined soft tissue temperature isreached. During the heating sequence the treatment energy source outputmay be variable. The temperature of the soft tissue may increase atleast twice and also decrease at least once until a predefinedtemperature is reached.

FIG. 3 illustrates one possible temperature profile of the soft tissue.The vertical axis in FIG. 3 symbolizes temperature of the specific softtissue layer (e.g. epidermis), and the horizontal axis symbolizes time.According to FIG. 3, at the beginning of the treatment a rapid rise ofthe temperature in the soft tissue may occur until the discomforttemperature level 301 a is reached. Then temperature of the soft tissue(e.g. epidermis) may be reduced by at least 0.2° C. or a value between0.2 to 4° C. or 05 to 3° C. or 1-2° C. to a comfortable temperaturelevel 302 a. Further temperate increases follow to a value of at least0.2° C. or a value between 0.2 to 4° C. or 0.5 to 3° C. to a temperaturehigher than the prior maximal temperature of the discomfort level. Suchheating profile may be practiced with multiple discomfort temperaturelevels e.g. 301 b, 301 c and multiple comfortable temperature levelse.g. 302 b, 302 c until a desired temperature 303 is reached. Betweentwo discomfort temperature levels temperature of the soft tissue may notbe reduced but may be kept constant for some time interval and thentemperature of the soft tissue may be reduced or raised again.Temperature heating profiles may be guided by operator, by control unit103 and/or by temperature control system 106, by energy generating unit105 and/or by the treatment energy source.

Methods of heating described by FIG. 3 may be useful to adapt heatsensitive skin receptors to higher temperatures of the soft tissue thanis normally comfortable, to prevent heat shock to patient's body, helpto adapt patient's body to treatment, stabilize biological processesduring the treatment and/or may enable reaching therapeutic desiredtemperature 303 in the soft tissue in shorter time. Such heating profilealso prevent that patient's body automatically starts to cool treatedbody area during the initial phase of treatment. Treatment may be moreeffective with lower energy losses and side effect to patient's body asa result.

According to another embodiment a heating profile of the patient's softtissue reaching predefined optimal treatment temperature may be at leastpartially exponential. After reaching the certain predefined temperatureand/or after specific time delay, heating and/or cooling may be slowedand temperature of the soft tissue may be kept constant. Priority ofsuch heating profile is to reach optimal treatment temperature as soonas possible and/or on the higher temperature value than is comfortablewithout such heating profile.

According to another embodiment a heating profile of the patient's softtissue in time may be defined at least partially by logarithmic, linear,periodical, or polynomial functions and/or a combination of thesefunctions where variables are temperature and time.

Time needed to reach optimal soft tissue treatment temperature accordingto the proposed device and method is after 7 minutes, more preferablyafter 4 minutes, more preferably after 2 minutes, more preferably after1 minute, even more preferably after 50 s, even more preferably after 40s, even more preferably after 30, most preferably after 5 s aftertreatment start. The therapeutic desired temperature may be kept for0.05-30 minutes or 0.2-25 minutes or 0.5-20 minutes or 0.2-18 minute.

The device and method produce temperature difference ΔT₁ between acontact part of the applicator and treated adipose tissue. Temperaturedifference ΔT₂ is created between epidermis and treated adipose tissue.Temperature difference ΔT₃ is created between epidermis and non-adiposetissue in dermis. Absolute values of the temperature difference ΔT₁ maybe in the range of 0-18° C. or 0-15° C. or 3-15° C. or 2-10° C., whereinthe adipose tissue has a temperature preferably higher than a contactpart of the applicator. Absolute values of temperature difference ΔT₂may be in range of 0-18° C. or 0-10° C. or 2-7° C., wherein the adiposetissue has preferably a higher temperature than the epidermis. Absolutevalues of temperature difference ΔT₃ may be in the range of 0-18° C. or0-10° C. or 2-8° C.

The heating source of the applicator may be a thermally regulated RFelectrode and/or a dielectric material located between treatment energysource and patient's surface (epidermis). The thermal gradient betweenthe RF electrode surface and the patient's surface may be in rangebetween 0-15° C. or 5-12° C. or 8-12° C. A thermal gradient between theRF electrode surface and the patient's surface may be influenced by adielectric material that may be localized between the RF electrode andthe patient's surface. Thermal conductivity of the dielectric materialat 293° Kelvin may be in range 0.001 to 500 W·m⁻¹·K⁻¹ or in range 0.015to 450 W·m⁻¹·K⁻¹ or in range 0.015 to 450 W·m⁻¹·K⁻¹ or in range 0.015 to200 W·m⁻¹·K⁻¹.

The device may comprise one or more sensors providing feedbackinformation to control unit 103, user interface 101 and/or to anindividual controlling mechanism. Based on evaluated feedbackinformation, treatment parameters may be adjusted by control unit 103,by a user and/or by any controlling mechanism. A sensor may be locatedin a heat exchanger, system enclosure and/or in the applicator. Sensorsin the device may measure: pressure under the applicator, temperature,viscosity of heat transmitter, flow of the heat transmitter, impedance,capacity, permittivity, conductivity, susceptibility of any part of thedevice and/or patient's body, sensors analyzing backscattered signal,infrared radiated spectrum and its intensity, heat capacity, voltage,electric current, phase shift of delivered and backscattered signal oftreatment energy, pulse of the patient and any other biological,biochemical and/or physical parameter e.g.: skin tension, muscletension, level of muscle contraction, amount of perspiration, breathingfrequency, etc.

Temperature of the soft tissue may be measured by a sensor directlyevaluating temperature as a physical quantity (e.g. thermometer, thermalimager, etc.) Another method to evaluate temperature may be by measuringa different physical quantity other than temperature, wherein thephysical quantity is thermally dependent (e.g. by measuring impedance ofthe soft tissue beneath the epidermis and counting soft tissuetemperature based on a correlation function that describes such softtissue dependence of impedance on temperature). Indirect methods ofmeasuring soft tissue temperature may be beneficial to evaluatenoninvasively temperature of the soft tissue under the epidermis, dermisand/or hypodermis.

According to another embodiment cooling of the patient's epidermis below20° C. may be provided. When skin surface temperature is decreased below20° C. pain receptors may have lower sensitivity. With cooling of thepatient's surface it is also possible to increase output power of thetreatment energy source 106 beyond the limit that is acceptable duringtreatment without regulation of the patient's surface temperature. Thismethod requires optimal adjusting of delivered treatment energyparameters in order to provide optimal homogeneity treatment.

As shown in FIG. 4, an applicator may have one RF electrode with upperpart 402 b and lower part 402 a. The RF electrode may include one ormore cavities 404 with the same or different volumes. Cavity 404 may befilled by heat transmitter through the inlet/outlet aperture 403 inorder to regulate electrode temperature or physical properties.

RF electrode 402 a-402 b may be at least partially covered by dielectricmaterial which may be divided into parts 401 a, 401 b and 401 c. Part401 a is dielectric material under the electrode and on the side of theRF electrode (especially lower part 402 a of the RF electrode). Part 401b may fix the dielectric material to other parts of the applicator andalso may hold other applicator parts together. Part 401 c is a vacuumedge that in combination with supplied vacuum under the applicator mayattach the applicator to the patient's surface. Dielectric material withparts 401 a-401 c may be designed as individual parts 401 a, 401 b and401 c or as one piece.

Vacuum may be delivered under the applicator by at least oneinlet/outlet vacuum aperture 410. This aperture may go through theelectrode around the electrode and/or through the part 401 a, 401 b or401 c of the dielectric material directly into the cavity 412 under theapplicator. According to FIG. 4 vacuum aperture 410 goes through the RFelectrode to the vacuum guide 411 leading to vacuum channel 408 in theelectrode and/or in the dielectric material. Vacuum channel 408redistributes vacuum around the electrode and to the vacuum pipe 409.Dielectric material may include one or more vacuum pipes 409 applyingvacuum to the cavity 412 under the applicator.

Isolating elements as an upper applicator lid 406 and an isolation forpower supply cable 407 may be attached to the electrode.

Individual parts of the applicator may be connected by connecting member405 (e.g. screws, glue, snapped to each other, molded to each other,connected by vacuum and friction forces, fixed by interaction betweenpolar and nonpolar groups of different materials and/or may be hold toeach other by magnetic and/or electromagnetic forces as described inU.S. Provisional Application No. 62/375,796 incorporated herein byreference.

According to one embodiment at least two parts of the applicator may beconnected together by dielectric material, e.g. in FIG. 4 dielectricmaterial including parts 401 a-401 c may hold together lid of theapplicator 406 upper and lower part of the RF electrode 402 b and 402 awithout need of screws and/or other fastening mechanism.

The method and device may be based on capacitive RF heating of the softtissue by bipolar and/or multipolar electrode arrangement with appliedvacuum under the applicator e.g. in the applicator's cavity 412 andcontrolled heating of the patient's surface by thermal diffusion. Oneapplicator may include one or more electrodes. The device may alsoinclude none, one or more RF electrodes heating the soft tissue by RFinductive heating e.g. heating of collagen fibers. The device mayinclude at least one applicator. According another embodiment RFelectrode(s) may be substitute and/or replenish by other source ofenergy than RF source of energy (e.g. by ultrasound transducer, lightenergy source and/or other).

The RF electrode(s) may exhibit multipolar system behavior where atleast one electrode is connected with RF energy flux density between atleast two another electrodes. One RF electrode and/or group of RFelectrodes including at least two RF electrodes may be switched on/offaccording treatment pattern as it is described in in U.S. ProvisionalApplication No. 62/375,796 incorporated herein by reference.

The distance between edges of the RF electrodes' treatment energysources may be at least 1 cm and/or be in the range from 1 cm to 40 cm,or 1 cm to 25 cm or 5 cm to 20 cm.

Target depth of the RF treatment energy may be between 0.1 cm 20 cm orbetween 1 cm to 20 cm or between 1.5 cm to 12 cm or between 2 cm and 8cm in the patient's soft tissue.

According to an exemplary embodiment the device includes an even numberof the applicators wherein each applicator includes one electrode (seeFIG. 4). A couple of such applicators exhibit bipolar system behaviorwith adjustable RF energy flux density between electrodes of theapplicators.

One or more electrodes may have different sizes and shapes thatinfluence the size of the treated area, focus of the treatment,parameters of provided treatment energy and/or homogeneity of thetreatment. Electrodes may be formed by conductive wire or system ofwires, by a conductive plate and/or other conductive or semi-conductiveobject. Shapes of electrodes may be asymmetrical or at least partiallysymmetrical e.g.: oval, elliptical, planar, square, wavy, convex,concave, spiral and/or other shape of electrode and/or shape ofelectrode surface. The electrode may consist of one or more pieces. Theelectrode with rounded edge(s) may minimalize edge effect and preventhot spot creation. According to a preferred embodiment an RF electrodehas a circular contour in longitudinal cross section and at least partlyelliptical shape of lower part of the electrode 402 a in vertical crosssection, as shown in FIG. 4.

Diameter of the RF electrode in FIG. 4 may be in the range from 0.6 cmto 40 cm or from 6 cm to 30 cm or from 6 cm to 15 cm or may have anyother diameter.

The RF electrode of the device may have different sizes and shapes.Surface size of the RF electrode contacting the patient (see lower partof the electrode 402 a FIG. 4) may be in range between 1 cm² to 1,200cm² or between 10 cm² to 800 cm² or between 30 cm² to 300 cm² or 30 cm²to 100 cm².

RF electrode may have also different surface modification e.g. eloxand/or other epoxy layer to prevent oxidation of the RF electrode.

In order to provide improved adjustment of delivered treatment energy,parameters may be used in an RF-regulating system (see FIG. 5). AnRF-regulating system may be part of treatment energy source 108 and/orenergy generating unit 105. RF-regulating system may include any partfrom the FIG. 4. e.g.: may include an HF generator 501, baluntransformer 502 that converts between balanced or unbalanced signal,impedance matching circuit (e.g. transmatch) 503, RF electrode 504and/or microprocessor 505. RF-regulating system may communicate withcontrol unit 103 or may be part of it.

According to another embodiment microprocessor 505 and/or other part ofRF-regulating system may not be included or may be part of anothercontrolling mechanism.

HF generator may be regulated in order to increase amplitude ofdelivered treatment energy signal and so increased output power of thetreatment energy source.

Balun transformer may transform balanced signal to unbalanced and viceversa. Balun transformer may transform signal before and/or afteradjusting signal by transmatch.

Transmatch may adjust frequency of treatment energy signal to optimizeselective heating of targeted tissue with minimal signal back scatteringand heating of unwanted soft tissue structure.

RF electrodes providing capacitive heating of the soft tissue createswith treated soft tissue an imaginary capacitor. In order to improveadjustment of delivered treatment energy parameters and capacity of suchimaginary capacitor may be adjusted according to the active surface ofthe electrode. RF electrode as treatment energy source may includeapertures. Size of the electrode's apertures may be varied and socapacitance of imaginary condenser created by two RF electrodes and thesoft tissue may be varied. Adjusting of RF electrode surface may be alsoprovided by other mechanism as described in U.S. Provisional ApplicationNo. 62/351,156, incorporated herein by reference.

The relative permittivity of a material is its (absolute) permittivityexpressed as a ratio relative to the permittivity of vacuum.

Permittivity is a material property that affects the Coulomb forcebetween two point charges in the material. Relative permittivity is thefactor by which the electric field between the charges is decreasedrelative to vacuum.

Likewise, relative permittivity is the ratio of the capacitance of acapacitor using that material as a dielectric, compared with a similarcapacitor that has vacuum as its dielectric. Relative permittivity isalso commonly known as dielectric constant.

According to presented device RF field is generated between at least twoRF electrodes that create a capacitor. Patient is located inside the RFfield. RF energy flux density is highest near the edges of the RFelectrode based on distribution of electric charge.

In order to prevent edge effects, rounded RF electrodes may be used thatmay have different thickness on the edges of the electrode than at thecenter of the electrode or the RF electrodes may have curved endingparts. Another mechanism how to prevent edge effect may be provided bychanging absolute value and/or shape of some RF field force lines.Changing shape and intensity at least locally may be provided by placingdielectric material and/or insulating material with different thicknessand/or relative permittivity across such material. As a result capacityof the capacitor created by the RF electrodes is locally changed and sogradient of RF field is changed that may cause homogenous tissue heatingand preventing edge effect.

Local capacity change is related to different dielectric materialthickness and/or relative permittivity between different locations belowRF electrode. That leads to definition of polarization factor definedas:P=ε _(r) d

where polarization factor P [mm] place is defined as relativepermittivity ε_(r) of dielectric material multiplied by thickness d ofdielectric material at exact.

Absolute value of difference between polarization factor below centre ofthe RF electrode and below edges of the RF electrode may be in rangefrom to 0.10005 mm to 19800 mm or from 1 mm to 800 mm or from 2 mm to600 mm or from 3 mm to 400 mm.

In order to prevent edge effect, improve focusing and homogeneity ofprovided RF energy into the soft tissue dielectric material part 401 amay be profiled. Profiled part 401 a of dielectric material may bethinner below the center of the RF electrode than below the RF electrodeedge. Thickness of profiled part 401 a of dielectric material below thecenter of electrode may be in range from 0.1 mm to 10 cm or from 0.5 mmto 1 cm or from 1 mm to 5 mm. Dielectric material below the electrode'sedge may be thick in range from 0.2 mm to 12 cm or from 1 mm to 3 cm orfrom 2 mm to lcm. Thickness of the dielectric material part 601 a belowthe electrode's edge may be at least 5% or 10% or 20% or 50% or 100% or300% thicker than is dielectric material below the center of RFelectrode.

Average dielectric constant of the dielectric material e.g. part 401 amay be in range from 1.0005 to 2,000 or from 1.1 to 150 or from 1.2 to100 or from 1.2 to 80 under the electromagnetic field with frequency 50Hz and temperature 298.15 K.

Stiffness of the dielectric material may be in range shore A5 to shoreD80 or shore A5 to shore A80 or shore A10 to shore A50 or shore A10 toshore A30. Dielectric material may be made of different polymericcharacterization.

As dielectric materials may be considered any type of gel and/or othersubstance located between applicator's contact part and patient's bodycreating layer thicker than 0.1 mm. Gels may help to improve energytransfer to patient's body and/or may realize active substance topatient's body in order to provide treatment more comfortable and/orimprove treatment results.

According another embodiment profiled part 401 a of dielectric materialmay be substitute by non-profiled part 401 a of dielectric material withdifferent dielectric properties at the edges of the RF electrode thandielectric properties at the center below the RF electrode. For exampledielectric material may have higher relative permittivity below theedges of the RF electrode than below the center of the RF electrode.

According to another embodiment the RF electrode may be thicker on theedges than in the center and/or RF electrode may also have roundededges. Such RF electrode embodiments may help to prevent edge effect andin combination with above described dielectric material, the edge effectmay be minimized or removed.

Prevention of the edge effect may be also provided by an RF electrodecreated from the planar winded coil where wire may have thicker diameterwith longer distance from a center of the winded coil and/or a distancebetween individual turns of the winded coil may be higher out of thecentre of the winded coil than near by the centre of the winded coil.

According to another embodiment some part of dielectric material, namelypart 401 a, may include one or more cavities inside. Cavity insidedielectric material may be filled with heat transmitter and may bethermally regulated and/or may change dielectric properties of suchdielectric material part.

Part 401 c of dielectric material called vacuum edge or vacuum cup maydefine a magnitude of a patient's skin protrusion, pressure value neededfor attaching applicator to patient's body and other properties. Vacuumedge 401 c may have a circular, rectangular or other symmetrical orasymmetrical shape.

Dielectric material parts 401 a-401 c may be rigid, at least partlyshape adaptive and/or at least partly elastic. Dielectric material fromat least partly shape adaptive material may provide flexibility to adaptapplicator surface to patient's surface and improve contact of thedielectric material with electrode and/or the patient body. Shapeadaptive material(s) may also improve energy transfer from applicator topatient's soft tissue. Dielectric material under the RF electrode may beany kind of polymeric material and/or blend of multiple materials withspecific dielectric parameters (e.g.: silicone, latex, rubber and/orother).

According to FIG. 4, a dielectric material may include parts as 401 a,401 b and/or 401 c. Dielectric material in the applicator may be createdas one piece including parts as dielectric vacuum edge 401 c, dielectriclayer under the treatment energy source 401 a (e.g. RF electrode) and/orat least part of the dielectric applicator covering 401 b. According toanother embodiment of dielectric material, the dielectric material maybe composed of several individually fabricated parts e.g. parts 401 a,401 b and 401 c. Individual parts or segments of dielectric material(e.g.: 401 a, 401 b, 401 c) may have the same or different mechanical,chemical, electrical, and/or magnetic properties (e.g. elasticity,stiffness, durability, dielectric constant, biocompatibility, etc.).

Optionally, an applicator may include flexible shape changing and/orelastic polymeric dielectric material as one piece including parts 401a, 401 b and 401 c which may provide better adaptiveness of theapplicator to patient's body, better integrity of applicator and easyway how to exchange this part which may be in contact with patientduring the treatment. Exchangeability of dielectric material may beconvenient to improve hygiene of the treatment, personalization forindividual patients and application needs and decrease costs of exchangeworn applicator parts. According to one embodiment dielectric materialmay be exchanged for another one and/or removed without need for screwsand/or technical knowledge.

Dielectric material (spacing object) located between patient's softtissue surface and treatment energy source may have specific propertiesand influence parameters of treatment energy as it is described in U.S.Provisional Application No. 62/331,072 is incorporated herein byreference.

According to another embodiment some part(s) of a contact applicatorpart may be omitted from covering by dielectric material, e.g.dielectric material under the treatment energy source may be at leastpartially omitted.

Vacuum (lower air pressure than is air pressure in the room) may be usedfor attaching of the applicator to a certain patient's body part, mayregulate contact area size of dielectric material under the treatmentenergy source with the patient's surface, may provide massage of thepatient's soft tissue, may help to reduce creation of hot spots and edgeeffect, may increase body liquids circulation and/or differentprotrusion shapes.

Regulation of vacuum may be provided in mother case as it isincorporated here in reference in provisional app. No. 62/375,796, inthe applicator (e.g. by Peltiere's member) and/or on the way betweenmother case and applicator (e.g. cooled in the heat transmitter guide).Regulation of the vacuum brought under the applicator may be executed byvalve, by construction of the device (mainly applicator) and/or bysystem regulation of output power of vacuum system.

The device may include one or more valves. Valves may be controlled bycontrol unit and/or may be self-controlled depending on the air pressurevalue in the cavity under the applicator and on the other side of thevalve closer to vacuum pump. One possible embodiment of self-controlledvalve is illustrated in FIG. 6. FIG. 6 illustrates vacuum inlet/outletaperture 602 located in wall 601 dividing environments with differentpressure value. The aperture is closed by closing object 603 pushed bysprings 604 against the wall 601 or by other mechanism. Springs 604 maybe fixed in closing object 603 and wall 601 or to other part of thevalve. Closing object 603 may be moved along rails 605 defining themovement path of the closing object 603. If air pressure on the valveside closer to the cavity under the applicator exerts higher force toclosing object 603 than springs from the other side of the closingobject 603 then valve is closed, if not the valve is opened. Opening andclosing valve may be based on different principle e.g. as one describedabove, regulating applied vacuum may be based on increasing/decreasingdiameter of aperture 602 and/or by another principle.

According another embodiment the device does not need to use any type ofvalve in the applicator. Design, material and number of device partsthat are involved to delivering of vacuum under the applicator mayregulate air pressure under the applicator also without any valve.According to one possible applicator embodiment illustrated by FIG. 4,the vacuum value (lowest air pressure) distributed to the cavity 412under the applicator with constant output power of vacuum system may beinfluenced by the number and/or diameter of vacuum pipe 409,inlet/outlet aperture 410, vacuum guide 411 and/or by channel 408.

According to another embodiment the applicator may be designed so thatvacuum under the applicator may change cross-sectional area of vacuumguiding part and influence air pressure value under the applicator.Change of vacuum guiding part cross-sectional area and/or shape may becaused by expansion, shape change and/or deformation of material(s)which the part is made of.

One example of expansion, shape change and/or deformation of vacuumguiding part may be FIG. 7 where 701 a is an aperture of guiding vacuumpart 702 during normal air pressure in the aperture 701 a and 701 b isan aperture of guiding vacuum part 703 during decreased air pressure inthe aperture 701 b.

Another example of expansion, shape change and/or deformation of devicepart involved to delivering of vacuum under the applicator may be FIG. 8where 801 is the patient's skin or surface, 802 dielectric materialincluding vacuum pipe 803 with no contact with patient's surface and 804is a dielectric material in contact with patient's surface that deformedvacuum pipe 805 by pressure of the patient's surface.

Vacuum under applicator may be constant and/or may be changed during thetreatment time.

Constant air pressure under the applicator may be provided bycontinually pumping air out of the applicator. According to oneembodiment providing constant air pressure lower than atmosphericpressure, vacuum system is operating during whole treatment and is notregulated by any valve. At the beginning of the treatment applicatorattached to patient body and may be fixed to specific area. After fixingapplicator to patient's surface vacuum system output power is decreasedto a value where air amount pervade from the outside of the applicatorto cavity 412 below the applicator is in balance with amount of suckedair from the cavity 412 below the applicator.

In other embodiment and/or treatment protocol vacuum output power may beconstant during at least part of the treatment, creating equilibriumbetween air pervading into the cavity below the applicator and airsucked out of the cavity, provided by the diameter and length of thevacuum related device parts under the applicator (e.g. 409 and/or 410see FIG. 4). The mechanism of such equilibrium is based on air frictionand turbulence in the narrow device parts.

Another mechanism for keeping constant pressure under the applicator isto regulate opening, closing and/or changing inlet/outlet aperture ofthe valve(s) when the pressure under the applicator is changed.

Constant pressure under the applicator may be provided by increasingoutput power, decreasing output power and/or switching on/off of thevacuum system.

Pressure under the applicator may be changed during the time of thetherapy. Changing pressure value under the applicator may be cyclicallyrepeated during the therapy. Such effect may be used as massage of theadjacent soft tissue. Massage of the adjacent soft tissue in combinationwith RF treatment energy source may accelerate treatment effect, improvetreatment results and decrease health risk. Massage of soft tissue mayimprove lymph and blood flow that improve heat distribution in theadjacent soft tissue that lower risk of creating hot spots and thermalinhomogeneity on the patient's surface. Massage in combination with RFtreatment energy source may accelerate fat metabolism, elastogenesisand/or neocollagenesis. Massage may stimulate movement of body fluids,as described in U.S. patent application Ser. No. 15/433,210,incorporated herein by reference.

Cycle changing pressure value under the applicator may be provided byincreasing/decreasing output power of vacuum system, by changingdiameter of inlet/outlet aperture for pumped air out of the cavity belowthe applicator, by closing/opening of at least one valve and/orcombination thereof.

Changing pressure value under the applicator may change contact area ofthe dielectric material 401 a or RF electrode with patient's surface.According to one embodiment, changing the pressure value under theapplicator changes protrusion of the soft tissue between vacuum edge 401c and dielectric material part 401 a. This may also change targetingand/or amount of delivered treatment energy source on the edge of thetreatment energy source (e.g. electrode) that may also prevent edgeeffect, creation of hot spots and other health risks.

Pressure value under the applicator may be changed compare to pressurein the room during the treatment in range from 0.1 to 100 kPa or from0.2 kPa to 70 kPa or from 0.5 kPa to 20 kPa or from 1 kPa to 10 kPa orfrom 2 kPa to 8 kPa.

Negative pressure created under the applicator may be lower compared toroom pressure in range 0.01 kPa to 100 kPa or from 0.1 kPa to 20 kPa orfrom 0.3 kPa to 50 kPa or from 0.3 kPa to 30 kPa or from 0.5 kPa to 30kPa.

The applied negative pressure may be continual or pulsed. Continualpressure means that the pressure amplitude is continually maintainedafter reaching the desired negative pressure. A pulsed pressure meansthat the pressure amplitude varies during the therapy. The pulsednegative pressure may alternate with peak pressure differences from 0.1kPa to 100 kPa with regards to pressure in the room (atmosphericpressure), more preferably from 2 kPa to 20 kPa with regards to pressurein the room (atmospheric pressure), most preferably from 2 kPa to 10 kPawith regards to pressure in the room (atmospheric pressure). Theduration of one pulse is in a range between 0.1 s to 1,200 s or 0.1 s to100 s or 0.1 s to 60 s or 0.1 s to 10 s; wherein the pulse meansduration between two beginnings of successive increases or decreases ofnegative pressure value.

In case of using pulsed pressure the ratio of P_(h)/P_(l) where P_(h) isvalue of highest pressure value a P_(l) is lowest pressure value duringone cycle of repeated pressure alteration may be in range from 1.1 to 30or from 1.1 to 10 or from 1.1 to 5.

According to one embodiment pressure in the cavity under the applicator412 may be continually decreased during initiating of the treatment andwhen pressure reaches a predetermined value, a pressure pulse cyclebegins.

Placing or holding of the applicators adjacent to the patient's body andswitching between them may be provided as described in U.S. ProvisionalApplication No. 62/358,417 incorporated herein by reference and/or in inU.S. Provisional Application No. 62/375,796 incorporated herein byreference.

In one aspect the device is designed as a belt that may be modularlymodified by adding and/or removing one or more part of the device (e.g.:applicators, treatment units and/or others) before and/or during thetreatment. The belt is designed to fit to any type and size of treatedpatient body area. In one preferred embodiment the belt is in touch withpatient's body surface matches the curvature of patient's body. Size ofthe belt may be variable by stretching and/or by plugging and/orremoving of one or more parts of the belt.

In another embodiment the belt may be considered as a block of at leasttwo treatment applicators attached in optimal working distance to thepatient's body. Optimal working distance may be any distance from theskin of the patient or in direct contact with the skin of the patient.Applicators may have various sizes and shapes.

Treatment applicators may provide different types of treatment therapye.g.: radio-frequency therapy (RF therapy), plasma therapy, ultra-soundtherapy, acoustic wave, shock wave therapy, light (coherent,non-coherent) therapy, heating, cooling, electro-therapy, therapy bygenerated magnetic field (include muscle stimulation), positive ornegative pressure therapy, vibration therapy and/or massage therapy.Treatments may be performed completely without attendance of theoperator and/or treatment procedures may by modified during thetreatment.

One or more treatment applicators may communicate with each other and/orwith one or more control units via cables, wireless and/or viaconnection through the belt. Transfer of the information through thecable may be based on conductive mechanism and/or via mechanism used inan optical fibers and/or as a wave guide provide transfer of differenttypes of the energy (e.g.: sonic, electric, electro-magnetic, pressureby liquid or gas substances and/or other). The communication may provideinformation about locations and/or type of the applicator/applicators,treatment protocol, treatment parameters and other information. In someembodiments it is possible to provide treatment between multipleapplicators, (e.g.: multiple monopolar, unipolar and/or multipolarapparatus) or focusing of some energy sources (e.g.: RF, ultrasound,light), that may improve some treatment (e.g.: removing of fattytissue).

Multiple treatment procedures and/or therapies may be combined at thesame time. This improves the effectivity of the treatment and/or reducesthe time needed for the treatment. It may also improve safety of thetreatment e.g. stimulation of soft tissue by massage improves blood andlymph flow which in combination with RF (radio frequency) therapy leadsto faster removing of treated fat cells (prevention of panniculitis),improves homogeneity of delivered energy and/or decreases influence ofedge effects and overheating of some part of the soft tissue due tobetter body liquid circulation than applying RF without massage.

The apparatus may operate without any operator which saves time andmoney. One operator may supervise more than one treated patient. Theself-operated device may prevent mistakes during the treatment caused byhuman factors. The self-operated device may also have a better responseto changed conditions of the treatment and/or may provide morehomogenous and precise treatment which improves results and safety ofthe treatment. With the apparatus controlled by a computer, responses tochanged conditions are improved because the apparatus can react on e.g.:moving of the patient or some structural changes in the soft tissue,etc.; faster than 0.1 s, and human response is at least 0.5 s.

The apparatus may be modular with a belt and/or arrangement of theapplicators providing an easy way to change treatment procedures andparameters before and/or during the treatment. One or more treatmentapplicators may be added or removed allowing for large scale treatmentprocedures, and modifying treatment parameters. Choosing suitableapplicators may influence successful treatment. Each patient may havedifferent body constitution with each patient consequently needingdifferent parameters of a procedure and/or a different arrangement oftreatment applicator(s), such as the number of applicators and/or typesof applied therapy.

Large scale modularity by changing hardware and/or treatment pattern byplacing of at least one applicator and/or other parts of the device,(e.g.: adding, removing, reorganization and/or changing of spacingbetween of at least one applicator and/or other part of the device)before and/or during the treatment allows actualization of the deviceand prevents obsolescence of the device. The belt may or may not containsupporting matrix. The belt may be flexible, whole or partly elastic andmay be adapted to patient surface of arbitrary size and shape. Thischaracteristic helps to provide optimal energy transfer from anapplicator to the patient soft tissue. Improved contact with the patientskin or surface may decrease or prevent an edge effect, backscatteringof delivered energy and/or provides better conditions for collectingfeedback information. Supporting matrix may also be connected to upperside of the applicator, keep one or more applicators in touch with thepatient surface, and not be in touch with the patient.

The belt may be a block of more than one applicator with and/or withoutsupporting matrix and/or with or without spacing object. Location ofindividual applicators (optionally including different types ofapplicators) creates a hardware pattern. A computer and/or operator maychoose several treatment therapies and procedures that can worksimultaneously, with some overlay and/or sequentially during thetreatment time and/or adjust one or more parameters of the procedurebefore and/or during the treatment.

Size of the applicator may be variable. Some of the applicator may haveseveral square millimeters of active surface and some of them may havemore than 10, 40, 50, 100, 200, 300, 500 centimeters square. Applicatorsmay also have different shapes. Some of them may have active surface ofsymmetrical shape (e.g.: square, circular, elliptical, triangular,teardrop, rectangular, spidery and/or other types) and some of them mayhave asymmetrical shape of active surface.

Curvature of the active surface of the applicator may be different thancurvature of other parts of the applicator. Active surface of theapplicator may have regular (e.g.: convex, concave, flat, etc.) and/orirregular curvature (e.g.: partly spherical, pointy, wavy, with someridge etc.), curvature of the active surface may also be composition ofseveral different curvature and/or active surface of the applicator mayhave at some area different curvature than is curvature at anotherspecific area of the same applicator. Curvature may create specificshape on the active surface of the applicator. Some types of applicatorcurvature may improve contact with the patient surface and/or modifypattern of deliver energy to the patient. Curvature of the activesurface may also sets working distance of the applicator and/or mayallow air (and/or liquid) flow under the applicator. In some embodimentsthe applicator curvature across its active surface may be changeableduring the time and/or curvature may be used as massage elements,especially when active surface is designed with some pattern.

Massage of the patient soft tissue may be provided by suction mechanismthat creates different air pressure above the patient skin and/ormassage may be provided by different automatic mechanism than suctionmechanism. Different manners of providing massage may be: mechanicalmassage by moving of at least one massage element; massage by switchingbetween parts of the device that creates mechanical pressure, massage bystimulation muscle fibers by electrotherapy, massage by sound and/orultrasound waves.

Active surface of the applicator may be designed from material that isable to adapt to any curvature of the body (e.g.: memory foam, elasticactive surface of the applicator, and/or any other material). Activesurface of the applicator may also contain one or more apertures ofdifferent sizes and shapes. Size and shape of one or more apertures mayby variable during the time of the treatment. Applicators may haveactive surface from different types of materials, different curvature,size and/or shape in order to improve specific treatment (e.g.: improveenergy transfer of specific treatment therapy into the soft tissue,improve contact of the applicator with patient body surface and/or otherpart of the device and/or in order to improve any parameter of thetreatment. Active surface of the applicator may be modified before,during and/or after treatment procedure by interchangeable attachmentsand/or by changing between different types of thin spacing objectsattached to active surface of the applicator.

According another embodiment applicator may also create treatmentpattern by switching on/off of some treatment elements included in theapplicator. In FIG. 21 element number 2101 is the applicator's activesurface with multiple treatment elements 2102. Applicator may containdifferent shapes of the treatment elements and number of the treatmentelements in one applicator is not limited. Spacing between treatmentelements may be different across the applicator's active surface.Treatment elements may also be movable during the treatment and/orspacing between treatment elements may also be variable during the timeof the treatment. Switching on/off of some treatment elements during thetime may be defined by protocol of the treatment procedure and maycreate multiple different types of the treatment pattern that may changeduring one treatment procedure. All of the treatment elements in oneapplicator may provide one therapy or in some other embodiment of theapplicator, treatment elements of one applicator may provide differenttypes of the therapies. Treatment pattern created by one applicator mayalso be created by moving of one or more treatment elements included inthe applicator.

Attaching of one or more applicators to patient body, to spacing object,to supporting matrix and/or attaching of the supporting matrix topatient body, to spacing object and/or to other one or more parts of thesupporting matrix and/or attaching other parts of the device together(e.g. treatment unit 2008 to a case or housing 2015 see FIG. 20) may beprovide by one or more different manners and/or combination of mannersdescribed below. Attaching may be provided via adhesive polymer orcopolymer (e.g. poly(styrene-ethylene-butylene-styrene) and/or others)which is located at the one or more contact sides of attaching parts ofthe device together and/or attaching one or more parts of the device tothe patient surface.

In another embodiment parts of the device may be attached to patientbody and/or to other parts of the device by a sticky layer betweencontact surfaces and/or by high adhesive layer applied on one or morecontacts surfaces. Contact between parts of the device and/or betweenone or more parts of the device and patient surface may be provided bygravitational force, by high roughness of the contact surfaces, byelectric forces, by magnetic forces, by rails, by elastic, partiallyelastic and/or non-elastic stripes, by Lace, by Velcro, zipper, bytacks, by creating lower air pressure between contact surfaces bysuction mechanism, by interaction between polar and/or non-polar groupof the contact surface, by fastening mechanism described below and/or byother physical, chemical, mechanical interaction between parts of thedevice and/or between patient surface. Some parts of the device may alsobe connected to each other by individual elements of a scaffold.

The belt may include supporting matrix that can hold one or moreapplicators and/or its treatment elements in touch with patient's bodysurface and/or it may also hold one or more applicators at an optimalworking distance from the patient surface. The patient surface istypically the skin of the patient. However, the patient body surface mayalternatively be some spacing object e.g.: clothing worn over the skin,a sheet, pad or other thin (0.1-2 mm) covering over the skin, and/or athicker spacing object.

Spacing object may be located between any parts of the device and/orbetween patient and some parts of the device. Because of mechanical,structural, physical and/or chemical properties of this spacing object,spacing object may provide and/or improve attachment of any parts of thedevice and/or some parts of the device and patient body surfacetogether.

The belt may encircle the patient's torso and/or limb, and optionallyincluding a fastening mechanism that may have various embodiments andmay help to fixe applicator(s) to supporting matrix.

The supporting matrix may include fastening mechanism for attachingapplicators to supporting matrix, for attaching some parts of thesupporting matrix together, for attaching supporting matrix to spacingobject and/or to patient's body and/or for attaching other parts of thedevice together. Fastening mechanism may also provide attaching one ormore applicators to spacing object and/or to patient's body. Fasteningmechanism may be e.g.: snap, clamp, some rails, adhesive polymer,pre-prepared holes, Velcro, zipper and/or other implemented fasteningmechanisms and/or snap mechanisms) and/or may be provided byelectromagnetic field, by magnetic field, by pressure lower thanatmospheric pressure, by adhesive material, by interaction of chemicalbounding interaction (interaction between polar and nonpolar groups)and/or others methods similar to method described above and/or othermechanisms.

The supporting matrix may contain fastening mechanism which may bepermanent or removable from the supporting matrix. Position of thefastening mechanism may be variable and/or fixed before, during and/orafter treatment. Fastening mechanisms may have various spacing betweeneach other, different shapes, sizes and/or mechanism, how to be attachedsome of the applicators and/or how to be attached to supporting matrixand/or how to provide other types of the connection described above(based on physical, chemical and/or mechanical interaction). Fasteningmechanism may be attached to supporting matrix and/or to arbitrary otherpart of the device at arbitrary location by similar manner as it isdescribed above—attachment of the applicator to patient's body and/or tospacing object. Fastening mechanism may be also attached to supportingmatrix and/or other parts of the device by mechanical connection.

One applicator may be attached across multiple fastening mechanisms(e.g.: applicators provide mechanical massage with movable and/or staticelement, RF therapy and/or other applicators provided different and/ormultiple types of the therapies). It is not necessary that supportingmatrix encircling whole patient torso and/or limb etc. In someembodiments applicators may be attached to both sides of the supportingmatrix.

The belt may comprise applicators applied on the patient surface and/ora thin and/or a thicker spacing object and fixed by textile, polymericand/or other strips. The strips may be at least partially elastic. Theapplicator(s) may be attached at the right working distance by one ormore stripes located in front and/or back side of the applicator.Suitable elastic materials are elastomers or also elastic fabrics. Theelastic belt material also adapts to respiratory movements and/or othermovement of the patient.

The applicators may have different sizes and shapes, to improvetreatment results and/or flexibility of the belt. Each applicator may befixed to supporting matrix at arbitrary position e.g.: by inserting anapplicator into the pocket in the support matrix, by Velcro and looptape, by one or more magnets, by tacks or fasteners, fastening strapsand/or by other fastening mechanism as may be seen in FIG. 19 and/or byother manner described above.

The supporting matrix may be attached to the patient by different waydescribed above and/or by encircling patient body and connect some partsof supporting matrix to each other and/or by external positive pressureacting on supporting matrix in direction to the patient surface.Supporting matrix may be designed as one or combination of more pieceswhere at least one piece has elastic properties. Supporting matrix maybe designed as elastic clothes (e.g. elastic trousers, sleeves, shirtetc.) to fix one or more applicators at optimal location on the patientbody and/or at optimal working distance with the patient body at theright position. Supporting matrix may be fixed at specific body locationof the patient body and/or may be movable along the patient body.

Some parts of the supporting matrix may be created of flexible, elasticand/or rigid materials e.g.: polymeric materials, ceramics, textilematerials, conductive parts and/or other materials. The supportingmatrix may be at least partially flexible and/or elastic to provideimproved contact with the patient body and/or set appropriate workingdistance for one or more applicators.

The support matrix may also contain apertures of different sizes andshapes. The support matrix may contain cooling/heating elements, massageelements that may move across the belt area and/or one or more sensors.In some embodiment mechanism for moving with attached applicators and/orother part of the belt may be provided according defined pattern. Atrack or path for the applicator may be created by rails (e.g.:applicator may be moved along them by mechanical forces based onpressure and/or tensile forces) and/or by a path created from conductiveelements and applicators may be moved along them by electric, magneticand/or electromagnetic forces.

Moving of one or more applicators and/or other parts of the belt acrossthe patient body may also be provided by moving of the supportingmatrix. Move of the supporting matrix may be provided by expansionand/or shrinking of some parts of the supporting matrix and/or by movingwith the supporting matrix along the spacing object (e.g. by mechanic,electric, magnetic and/or combination of these forces) and/or byattaching supporting matrix to an another movable parts of the device(e.g.: mechanical arm, construction on rails).

The supporting matrix may have several embodiments. One of suchembodiment is depicted in FIG. 19 where the support matrix consists ofguiding scaffold 1903, with the one or more applicators 1901 attachableto the scaffold 1903 by fastening mechanism 1902. The supporting matrixmay include conductive parts that may provide communication betweenapplicators, communication between applicators and central control unitand/or communication between at least one applicator and treatment unit.Conductive parts in the supporting matrix may also provide power supplyto the applicator(s). Applicator may also include one or morerechargeable batteries as a source of energy. These batteries may berecharged through the supporting matrix and/or through the spacingobject.

In another embodiment belt may be a flexible textile and/or polymericsheet. This sheet may contain conductive elements that may providecommunication, power supply, determine of one or more applicatorslocation and type, contact with the supporting matrix and/or patientsurface, provide information about treatment protocol as was mentionedabove and/or other features. In some embodiments supporting matrix mayalso include cooling and/or heating components. This embodiment of thebelt may also include spacing object.

Feedback information may be collected by different types of sensors andmay have different characters e.g.: biological, chemical, physical etc.One or more sensors may be located in the belt (in supporting matrixand/or in the one or more applicators) and/or externally out of the belt(e.g.: optical, sound and/or others located around a patient). One ormore sensors may control parameters of the treatment procedure e.g.:intensity of delivered energy into the tissue, burst rate, changingparameters of the delivered signal and/or switching on/off of differenttreatment procedures and/or others. The device may contain differenttypes of sensors for monitoring device parameters, monitoring of bodybiological, physical, chemical and/or other parameters (e.g. anelectrochemical sensor; a biosensor; a biochemical sensor; a temperaturesensor; sensor for measuring distance of applicator from the patientsurface, from some area of the patient soft tissue and/or from otherapplicator (determine position of the device); a sensor for recognitionof applicator orientation in 3D; rotational orientation sensor; asorption sensor; a pH sensor; a voltage sensor; a detector of movingvelocity and/or change of position; photo sensor; sensor measuring fluidviscosity; a camera; a sensor for measuring fluorescence of the patientsurface; a sound detector; a current sensor; sensor for measuring ofspecific heat capacity of human/animal tissue; a sensor for measuringvalue of magnetic field; sensor for measuring impedance; permittivity;conductivity; susceptibility and/or any suitable sensor or sensorsmeasuring biological parameters and/or combination thereof e.g.: sensorfor measuring dermal tensile forces; sensor for measuring the activityof the muscle; a sensor for measuring muscle contraction forces; sensorfor measuring pulse of the patient; a sensor measuring skin elasticity.The device may also include at least one contact sensor for monitoringapplicator contact with body surface of the patient. Supporting matrixmay also recognize type and/or location of the different one or moreapplicators attached to the supporting matrix.

As a result, so-called plug and play methods may be used to modifyhardware pattern of the applicators attached to patient and/or tosupporting matrix (sorting and/or choosing of the applicators). Thisplug and play method provides a large scale of modularity. Thesupporting matrix also may recognize which applicator is positioned orfixed in which slot in the supporting matrix and the control unit mayassign and/or accept predefined treatment protocols. Recognition of theapplicator may also be provided by one or more central control unitsand/or by any other one or more control units. Localization of theapplicator may be provided by some specific sensors described below.

Applicators may be able to communicate with each other and/or withcentral control unit see FIG. 18 by wire and/or wirelessly. Thiscommunication may provide information from feedback sensors, aboutposition of one or more applicators, 3D orientation of the applicator(s), information about contact of the applicator (s) with the patient,distance from the patient surface, parameters of the treatmentprocedure, parameters of each applicator and/or other information fromone or more sensors. Data from a different applicator may providecomplex information about the treatment and/or treated soft tissue.Information from the sensors may be used to determine which part of thepatient is treated, determine the exact composition of treated softtissue and/or changes in the soft tissue during the time of thetreatment.

These sensors may cooperate with one or more applicators (e.g.: providedultrasound, RF, electro-magnetic source of energy) and may be used asimaging device of surface and/or deeper layers of the patient softtissue. Imaging system of the soft tissue before and/or during thetreatment may improve safety of the treatment, determine when thetreatment is complete, and/or monitor process and/or progress of thetreatment. This processed data may be used for adjusting parameters ofthe treatment procedure, may activate other treatment therapies and/orone or more procedures (activate massage, cooling, heating and/orothers) and/or change any other parameter of the treatment. This datamay also warn operator and may be used as prevention of health risk.

Treatment procedures may include several instructions that definetreatment of one applicator. Treatment procedures include e.g.: defineone or more applied therapies, shapes and types of a delivered signalinto the soft tissue (symmetrical; asymmetrical; polarized;non-polarized; continual or sequences of signal pulses; timing of thedelivered signal; shape of the signal: sine, square, triangle, saw toothand/or others), define pulse sequences intensity of delivered energy,polarization of delivered electro-magnetic signal, remaining time oftreatment procedure, threshold parameters, time and/or sequence ofheating/cooling of the soft tissue and/or other parameter that influencetreating of the soft tissue by one applicator (e.g.: geometry andposition if it is possible to change this parameters and/or otherparameters).

Several applicators may cooperate with each other. FIG. 17 describescooperation of multiple applicators 1701 a, 1701 b, 1701 c that mayprovide some treatment therapy (e.g. multipolar RF therapy symbolized byfield lines 1702 and/or others) to the patient 1703. Cooperation ofmultiple units may be used for different therapies (e.g.: RF,ultrasound, light, massage, cooling/heating, electrotherapy,magneto-therapy and/or other therapies) in order to provide bipolarand/or multipolar treatment across large patient area, better targetingof delivered therapy, better focusing of delivered signal, creating ofsome gradient in the soft tissue (e.g. thermal gradient, etc.), betterhomogeneity of provided therapy across large patient area and/or volumeof the soft tissue.

Cooperation of multiple applicators and/or treatment elements mayenlarge treatment variability (e.g. treatment depth, focusing), sincethe electrode of each applicator and/or treatment element may representsone pole of multipolar treatment.

In order to provide safe multipolar treatment across multipleapplicators this process may be guided by one or more central controlunits and/or by at least one control unit of the treatment unit and/orby external control unit in cooperation with sensors and otherinformation (e.g.: placement and distances between specific 5 types ofthe applicators). This method may provide safe and targeted treatment.

Communication between applicators, central control unit, other controlunits, user interface, and/or other parts of the device may be based onpeer to peer principle and/or communication may be based on master/slavemodel where one of the units has higher priority than others and managesthe treatment. Higher priority may also have a group of more than onecontrol unit and/or the highest priority may be redirected to one ormore others units during the treatment. Redirection of the highestpriority may be based on feedback information, treatment protocol and/oroperator guidance.

A central control unit which may be guided by internal protocol and/orby user interface. Based on this information the control unit in eachapplicator and/or control unit of the therapy (see FIG. 18) may changetreatment parameters. FIG. 18 also symbolize mechanical Emergency stopbutton that unplug device or only parts of the device, that providesenergy to the patient, from the power supply by manner that stops alltherapies and switch off the device by safety way. Switching off one ormore therapies and/or some parts or all parts of the device may beguided by control unit with the highest priority.

The operator may change and/or set one or more treatment parameters andprocedures through the user interface located on base unit that mayinclude central control unit and/or on the treatment unit that mayinclude control unit of the therapy. The operator may change, set and/oradjust any treatment parameters and/or procedure before and/or wheneverduring the treatment. Software controls safety of the treatmentparameters and if some of them are valued as dangerous, software warnthe operator and propose safety one. If a sensor detects critical valueof specific parameter (e.g.: temperature, time, dosage intensity and/orothers), operator may be warned and/or the procedure and/or treatmentparameters are changed according predefined safety protocol.

Software may include different specific safety protocols and others maybe created. The user may also be able to select one or more ofpredefined treatment protocols and/or operator may create a newtreatment protocol. Treatment protocol includes data about treatment(e.g.: treatment parameters, procedures, localization and/or orientationof each applicator, information about treated body and treated areas ofthe body). The control unit may be able to learn in order to modify andimprove treatment protocols based on analysis of stored data fromprevious one or more treatments.

In FIG. 20 a case 2015 contains central unit 2013 of the case 2015 andone or more treatment unit (2008 a-2008 d) that may contain one or morecontrol unit of the therapy. The central unit 2013 of the case 2015 asthe only one may include one or more central control units. Case 2015may include slots for specific treatment units. Treatment unit may befixed in the right position by specific type of fastening mechanism thatis described above. Connection between case and treatment unit may bewireless, by cable 2003, by contact pins, one or more magnets, one ormore conductive parts and/or by chassis. Recognition of the treatmentunit may be through specific impedance, RFID tag, pins, sequence ofspecific electrical and/or electromagnetic pulses measuring of magneticfield that may be specific for individual type of the treatment unit,software recognition and/or through other one or more mechanisms.Described system for recognition of the treatment unit may also be usedfor recognition of individual applicator.

According to still another embodiment the case 2015 may provide one ormore treatment therapies without connecting to one or more treatmentunits 2008.

Central unit 2013 of the case 2015, applicator(s) and/or one or moretreatment unit (2008 a-2008 d) may contain emulator software and/orhardware to provide communication between each other and/or an externaldevice.

Number of units that are able to communicate between each other is notlimited. Each of these units may provide software and/or hardware forcontrolling and/or providing one or more specific therapies.

The therapy (e.g. RF, ultrasound, and others) may be controlled throughthe specific treatment unit or units (2008 a-2008 d) for this therapy byhuman-machine interface, by some protocols that may be included in oneor more central control units and/or other control units and/or throughexternal protocol.

Human-machine interface may include user interface that may be includedin one or more treatment units (e.g.: circle control element 2007 mayhave rotational and/or pushing controlling function treatment; somebuttons 2009 a, secondary display 2006 may be touch; button 2005 whichsignal if the unit 2008 a-2008 d is switch on or off and/or others)and/or user interface include in central unit 2013 of the case 2015(e.g.: circle control element 2014; several buttons 2009 b; primarydisplay 2002 may be touch; emergency stop button 2010 and/or others).The device may also have external human machine interface. The devicemay also include external emergency stop button 2011 for the patientwhen the patient feels uncomfortable.

Information about attached applicators, parameters of the therapy(s)and/or procedure(s) may be displayed on the secondary and/or primarydisplay. Some parameters of specific therapy may also be adjusted and/orchanged by other one or more treatment units that are not intended forthis therapy. Unit 2008 a-2008 d may be connected by cable 2012 b and/orwirelessly to belt and control it. Unit 2008 a-2008 d may also beconnected to other one or more treatment units by cable 2004 and/orwirelessly and/or may be connected to central unit of the case 2013, bycable 2003 and/or wirelessly.

Through the central unit 2013 of the case 2015 may be controlled allparameters of the treatment. The central unit 2013 of the case 2015 maybe connected to belt wirelessly and/or by cable 2012 a. Each part of thedevice that is needed to be provided by power supply may be connected toother part of the device that is powered and/or may be connected topower supply by cable 2001. Separation of treatment unit(s), and/orother part of the device may be very effective system for improvingmodularity. During the time it is possible to invent new treatmentdevices, applicators, methods and/or protocols that can be in easy wayimplemented in new specific unit similar to unit 2008 a-2008 d andconnect to presented method and device. The central control unit,control unit of the therapy and/or other control units may be designedfor software update through the cable and/or wireless connection (e.g.through internet network, actualization device and/or other methods).The device may also be able to download new software, treatmentprotocols and/or other parts of the software. Device may also beinterconnected with some other devices (e.g. computers, tablets, smartphones) that may help operator to control treatment and adjust it withlimited manner. It may be also possible to check proper functioningthrough the internet by authorized person.

The device may also include counter. The counter is a part of the devicethat is able to count number of therapies, time of providing specificone or more therapies, parameters of treatment(s) and/or treatedpatient, number of cycles of specific one or more therapies and/or othermeasurable properties connected to the treatment. Data from the countermay be saved into the memory that may be accessible only for authorizedone or more persons and/or data from the counter may be sent by networkto external storage. The device may also communicate with one or moreother devices and/or with human/machine interface and inform user and/orauthorized person about actualization, service, about billing system,about wear of specific parts of the device etc.

The counter may also contain unit that is able to provide test of thefunctionality of the device and/or measuring response of some parts ofthe device.

The device may also be equipped or connected to some device that iscapable to demonstrate patient process and/or progress of the treatmentand/or compare running treatment with previous treatment of the sameperson or to other persons.

The present device and method may provide different types of energies inorder to provide treatment as described above. The device preferablyuses an RF treatment energy source.

Waves of the RF energy may be delivered in the range from 0.1 MHz to 2.5GHz or from 0.1 MHz to 300 MHz or from 0.1 MHz to 100 MHz. The RF energymay be provided in one, two or more frequencies to a patient's bodysimultaneously or sequentially. Such energies may be provided by one ormore different sources of energies e.g. based on capacitive and/orinductive RF electrodes.

According to one embodiment and a method of use, an experiment provedsignificantly improved treatment results when at least one monopolarelectrode produced RF energy up to 1.5 MHz and at least one pair ofbipolar electrodes produced RF energy in range from 20 MHz to 35 MHz.

According to another embodiment and method of use at least two differentRF energies may be simultaneously provided to patient's body atfrequencies in range from 25 MHz to 30 MHz.

According to another embodiment treatment RF energy may be modulated tofrequencies in a range from 50 kHz to 1 MHz or from 50 kHz to 500 kHz orfrom 100 kHz to 300 MHz.

Different RF frequencies may be used during one treatment session,targeting different soft tissue structures and soft tissue depths.

According to another embodiment, RF waves in microwave range from 300MHz to 300 GHz may have several benefits namely in combination withdielectric material 601 a located between treatment energy source andpatient's soft tissue surface. Advantages and parameters of treatmentmay be used as described in U.S. Provisional Application No. 62/331,072incorporated herein by reference.

According to some embodiments, instead of RF electrodes, one or morewaveguides and/or antennas may be used that enable the use of RFfrequencies up to 2.5 GHz.

An electromagnetic field may be applied to the patient body in continualand/or pulse modes. Continual irradiation of a body area by RF may be atleast 5 s or 20 s or 30 s or 60 s or 120 s or 240 s or 10 minutes or 20minutes or more than 20 minutes or the most preferably more than 35minutes.

The pulsed electromagnetic field may last between 50 μs to 100 s, inmore preferred protocol pulse may last between 1 s to 70 s, and in themost preferred embodiment pulse may last between 3 s to 70 s.

An RF treatment energy source may be adjacent to the patient's softtissue in contact mode where RF treatment energy source (electrode) isin contact with the patient's surface, indirect and/or in no-contactmode, i.e., with the electrode not in contact with the patient surface.

Energy flux density (energy flux density on the electrode surface) ofthe electromagnetic field in noncontact mode, where electrodes providingRF signal are spaced from the patient body by an air gap may bepreferably in the range between 0.01 mW·mm⁻² and 10 W·mm⁻², morepreferably in the range between 0.01 mW·mm⁻² and 1 W·mm⁻², mostpreferably in the range between 0.01 mW·mm⁻² and 400 mW·mm⁻².

Energy flux density of the electromagnetic field in contact mode(including the direct contact of electrodes coated by thin layer ofinsulator) may be preferably in the range between 0.01 mW·mm⁻² and 2,000mW·mm⁻², more preferably in the range between 0.01 mW·mm⁻² and 500mW·mm⁻², most preferably in the range between 0.05 mW·mm⁻² and 280mW·mm⁻².

Energy flux density of the electromagnetic field in noncontact modewhere electrode is spaced from the patient body by dielectric materialwith beneficial dielectric parameters e.g.: using a spacing member sucha flexible container holding a bolus of water, silicon and/or othersdielectric materials) may be preferably in the range between 0.01mW·mm⁻² and 500 mW·mm⁻², more preferably in the range between 0.01mW·mm⁻² and 240 mW·mm⁻² or even more preferably in the range between0.01 mW·mm⁻² and 60 mW·mm⁻² or the most preferably in the range between0.05 mW·mm⁻² and 12 mW·mm⁻².

RF electrode may operate in capacitive and/or inductive mode. Accordingto preferred embodiment capacitive mode providing selective and safetreatment may include RF-regulating system (see FIG. 11). RF-regulatingsystem may be part of the energy generating unit 105, control unit 103and/or may be located individually and may communicate with control unit103.

Parameters of RF treatment energy may be also modulated (adjusted) asdescribed in U.S. Provisional Application No. 62/333,666 incorporatedherein by reference. According alternative embodiment applicator may bemovable as described in U.S. Provisional Application No. 62/331,088incorporated herein by reference.

As shown in FIG. 22, a system is provided for treating large areas orparts of the body 2201 with minimal need of personnel assistance duringtherapy. Multiple electrodes 2202 may be arranged adjacent to eachother, with the electrode interconnected and partially separated fromeach other by carrier surface 2203. If the electrodes are made of rigidmaterial the spacing between the electrodes allows for flexiblepositioning of the electrodes on the body 2201. However, preferably theelectrodes are made from flexible material. The electrodes can beselectively switched on and off during treatment, optionally in a way sothat adjoining electrodes are not powered on at the same time. Thisswitching, if used, may be controlled by the microprocessor control unitand be set by the user in a user interface, or it may be setautomatically based on treatment type.

The new methods include application of radio frequency waves of variouswaveforms that are delivered to the treated tissue. Some particularexamples of these waveforms with varying parameters are shown in FIG.23-28. The waveforms are generally described for one source ofelectromagnetic power. However, more than one source may work in thesemodes. The waveforms being just a schematic representation of fieldoscillations in time, they may be related to both electric and magneticpart of the electromagnetic wave. The peak amplitudes and instantaneousamplitudes shown in FIG. 23-28 can thus represent either the electric orthe magnetic field strengths and for sake of simplicity, they will bedenoted just as peak or instantaneous amplitudes in furtherdescriptions.

FIG. 23a is a schematic plot of instantaneous amplitude of anelectromagnetic wave against time in the simplest pulsed mode. Pulseduration Tp determines the time when the source of radio frequencyradiation is on. Within the pulses 2302, a sine wave 2301 of apredetermined frequency is delivered, oscillating between the positiveand negative value of peak amplitude Ap. Pulse spacing Ts is the periodwhen the source of radio frequency radiation is off between twosubsequent pulses 2302. Cycle time Tc can then be expressed as Tc=Tp+Ts.Duty cycle D is the ratio of the ON time to the total ON plus OFF timefor one complete cycle of operation, in other terms: D=TP/(TP+TS). Adwell time Td between two groupings of pulses may also be introduced.For the sake of simplicity, a grouping 2303 comprising only 3 pulses isshown in FIG. 23a . However, the real number of pulses per grouping ismuch higher, and in many applications, the pulses are deliveredcontinuously, spaced by regular intervals Ts, i.e. with Td=0.

The peak amplitude Ap, the frequency, the pulse duration Tp and thepulse spacing Ts, and thus the duty cycle D, can be varied and/oradjusted during the therapy. The number of pulses per grouping of pulsesand the dwell time between two subsequent groupings can be varied aswell.

Peak amplitude and frequency values and their possible variations duringthe therapy will be discussed in the next sections.

In special cases, the frequency can be modulated within the pulses 2302,as shown in FIG. 23 b.

Amplitude modulation, i.e. the modulation where the peak amplitude Apchanges over time, can also be used in pulsed mode. In this case, signalenvelope 2304 is defined as a smooth curve outlining the waveformextremities, as shown in FIG. 23c . Whereas the signal envelope in FIG.23a is a rectangle, in FIG. 23c the signal envelope 2304 forms a part ofa sine wave 2301. Other signal envelope forms are also possible, e.g.triangle, saw tooth or many others. Similarly, the envelope of an idealrectangular pulse shown in FIG. 23a can be intentionally modified bychanging the form of the leading edge from very steep to rising moreslowly. The trailing edge can also decay more slowly, as shown in FIG.23 d.

Both frequency and amplitude modulation and the forms of envelopes andedges, can be varied according to the temperature and/or impedancefeedback, previous experience and the desired therapeutic effect.

The pulses as shown in FIG. 23a are alternated with simple pauses. Inanother aspect of the invention, they can be alternated with activecooling of the adjacent parts of the body, which is useful especiallyfor the treatment of tissues at depth.

FIG. 24 shows schematically an example of pulsed radio frequency heatingand alternating cooling as a function of time, with resulting timeevolution of the first temperature 2404 at the skin surface and of thesecond temperature 2405 at depth. It is only a schematic illustration ofthe procedure, the precise data depending on many tissue andelectromagnetic radiation related parameters. The pulsed radio frequencyheating 2302 is applied during time interval 2403, following the coolingtime interval 2401. As an option, a short delay 2402 may follow thecooling period before the heating pulse starts. Such alternatingsequences of cooling and heating may be periodically repeated.

When the surface of the skin is exposed to an active cooling 2406, thefirst temperature 2404 at the skin surface drops to a level determinedby the cooling time interval 2401. The second temperature 2405 at depthis initially not significantly affected by the cooling and may drop onlyslightly. When the heating pulse is on, the second temperature 2405 atdepth rises, while the surface tissue is still kept below the threshold2407 for damage temperature, due to the precooling and/or to the depthand/or tissue selective parameters of radio frequency pulse.

Besides the pulsed cooling mode shown in FIG. 24, a permanent cooling isalso possible. As another option, permanent cooling to a highertemperature (e.g. 36° C.) may be associated to a pulsed cooling to alower temperature (e.g. 30° C.). As yet another option, permanentcooling to a lower temperature may be associated to a RF heating to ahigher temperature.

In yet another aspect of the invention, radio frequency heating withlower power and/or different frequency and/or different wave amplitudesmay also be applied during pulse spacing Ts periods, as shown in FIG.25. The reduced power and/or modified frequency TL between the mainpulses TF help to prevent overheating. Also, other structures atdifferent depths can be heated by these intermittent radio frequencywaves. One or more sources of radio frequency waves may be employed toachieve this effect.

Pulsed therapy is preferentially continuous, in the sense that thepulses follow each other fluently with regular pulse spacing Ts and thedwell time Td can be set to 0, as there is generally no need tointerrupt the treatment for overheating, which is sometimes the casewith continuous radio frequency waves.

Pulsed radio frequency mode, especially when used with temperatureand/or impedance measurement feedback, offers the advantage of efficientheating and/or stimulation of the targets at depth, without thesurrounding tissue destruction and painful sequelae. These side effectsare sometimes associated with continuous radio frequency therapy when itis used to heat the deeper layers of the skin. As the tissue heatingdecreases rapidly with the distance from the radio frequency source,relatively high powers are necessary to achieve therapeutic temperatureat deeper layers of the skin.

In continuous mode, these high powers can cause tissue destructionespecially in tissues having higher water content and thus higher radiofrequency wave absorption, as the epidermis or dermis. Standing wavesleading to hot spots creation represent another drawback of thecontinuous radio frequency therapy. When the pulse therapy is properlyadjusted, the hot spot creation is nearly excluded, and due to thepauses between the high power pulses, harmful heat-induced effects whichwould arise with the same high power applied in continuous mode, areavoided. The reason is that during the pauses between the high powerpulses, the radio frequency heating works at reduced power or iscompletely off. Active cooling of the surrounding tissues can also beemployed. The pulse spacing Ts provides time for heat elimination,generally keeping the surrounding tissues below the damage temperature.The preferred pulse spacing Ts is less than or equal to the thermalrelaxation time of a targeted structure.

Amplitude or frequency modulation, as they were described withinindividual pulses in the pulsed regime, can be employed in continuousmode as well. This represents a supplementary tool to adjust thepenetration and heating efficiency parameters of the radio frequencywaves. An example of amplitude modulation of a continuous wave 2602 witha sine envelope 2601 is shown in FIG. 26. An example of frequencymodulation of a continuous wave is shown in FIG. 27. Other envelopeforms are also possible, as well as different indexes of the frequencymodulation.

Even if there is no frequency modulation, the frequency can beadvantageously adjusted to different values during different intervalsof the treatment. This frequency variation may be used to enlarge thepossibilities of all the above described modes, and also in continuousmode.

It has been found that the higher the frequency, the more enhanced theeffect of power intensity on the tissue and the faster the heating,which is true in particular for polar tissues such as dermis, epidermisor muscles. The reason is that the high frequencies are stronglyabsorbed and thus quickly transformed into heat in polar tissues. As aresult, microwave frequencies, e.g. 2.4-2.5 GHz, are well suited forepidermis and dermis tissue heating, and also for muscle diathermy ifthe power is sufficiently high even after absorption in the moresuperficial skin levels. However, in some conditions, e.g. for higherpowers needed to penetrate really deep layers, the heating ofsuperficial tissues by microwave frequencies might be excessive, whichwould discourage the use of these high-frequency microwaves incontinuous mode without cooling. Proposed solutions to this probleminclude: lowering the frequency e.g. to 902-928 MHz or even lower, orswitching on the active cooling or passing from the continuous mode tothe pulsed mode.

It has been found that the depth of penetration decreases withfrequency, and namely those frequencies of 902-928 MHz or lower canpenetrate more deeply into the tissues than the microwave frequencies.The advantages of lower frequencies for diathermy include less severestanding waves and less resulting hot spots in the fat, and betterknowledge of the absorbed energy for a large variation of skin layerthicknesses, as the temperature distribution in the tissues is moreuniform at frequencies of 902-928 MHz or lower. However, heating atlower frequencies is slower.

The non-polar tissues, e.g. the adipose tissue, are also heated slightlyfaster at higher frequencies. The adipose tissue being situated justbeneath the relatively thin layer of epidermis and dermis, the overallabsorption of high frequency waves in these superficial layers ismoderated and it appears that micro wave frequencies, e.g. 2.4-2.5 GHz,are well suited for fast adipose tissue diathermy. However, shorterfrequency waves might also be attractive for adipose tissue heating insome cases.

The shorter frequency wavebands that may be used for frequency variationinclude the following ranges: 902-928 MHz, 433.05-434.79 MHz,40.66-40.70 MHz, 26.957-27.283 MHz or 13.553-13.567 MHz.

In yet another aspect of the invention, the power of the radio frequencywaves can also be advantageously adjusted. This adjustment can beperformed in continuous mode or in any of the modes described above,including their mutual combination. It is well known that the power islinked to the amplitude of electric or magnetic field strength, theseamplitudes being schematically plotted in FIGS. 23-28.

The power is adjusted according to the therapy process. Examples areshown in FIGS. 23c, 23d , 25, 26, 28 a and 28 b. For instance, in thecase shown in FIGS. 28a and 28b , the power is temporarily increased atthe beginning of the therapy, leading to a rapid increase intemperature. The therapeutic temperature can be reached in shorter timeand the total duration of the therapy is thus optimized. Preheatinginterval 2801 is either predefined or dynamically adjusted according tothe feedback measurements. Most often, the preheating stops when thetherapeutic temperature is reached. Also, it can be stopped when aspecific temperature gradient in the targeted tissue is achieved, orafter a predetermined time. After the preheating, the treatment cancontinue at reduced power, as shown in the examples of FIG. 28a forcontinuous treatment, and in 28 b for pulsed treatment. This reducedpower is generally sufficient for maintaining the therapeutictemperature. This procedure helps to avoid overheating of the tissues.Also, it optimizes the temperature profile and makes the results of thetherapy repeatable, given that the main part of therapy starts atwell-defined conditions, most often with the targeted tissue preheatedto a defined temperature. It is advantageous that the reduced powerwhich is delivered after the preheating interval 2801, can be eitherpredefined or dynamically adjusted according to the feedbackmeasurements. In other cases, the therapy can be continued by switchingto any of the above described modes or their combinations, according tothe targeted therapeutic effect. Most often, the maintenance of thetherapeutic temperature is sought, and the power applied within themodes following the preheating interval 2801 can be lowered.

When only a smaller temperature gradient in the targeted tissue isrequired, it is possible to start the diathermy by delivering a smallerpower and preheat the targeted tissue to some temperature lower than thetherapeutic one, as shown in FIG. 25. Then, the therapy can be continuedby any of the above described modes.

All the above mentioned methods, i.e. the emission modes includingpulsed mode, continuous mode, amplitude modulation mode, frequencymodulation mode, frequency adjustment, power adjustment and differentcooling modes, can be mutually combined.

For the purpose to utilize some of benefits of penetration,polarization, dispersion, targeting, filtering, absorption, changing ofenergy transfer properties and/or other manipulation withelectromagnetic wave is advantageous to use microwave in the range of300 MHz and 300 GHz which results from the used wave length. Wavelengthhas crucial influence for biological effect and modification of wavecharacter Thanks to wavelength it is possible to influence polarizationand/or other characteristics of the electromagnetic waves. Anotherbenefit of microwave is that microwaves in comparison with short waveshas shorter wavelength therefore more similar to size of some cellsand/or molecular systems and/or structure and that is the reason why itis possible to directly and selectively influence this structure indesired manner. It is also known that microwave has dominant electricalcomponent of electromagnetic radiation, which may be advantageously usedfor treating mostly subcutaneous fat and/or cellulite primarily bythermal heating

According to still another embodiment, muscle stimulation or of othersoft tissue structures, stimulation by electrical current and/or bymagnetic field may be also used as type of soft tissue massage. Musclestimulation may improve targeting of heating up of soft tissue, providebetter homogeneity in delivered energy, prevent local hot spots, improveblood and lymph circulation and/or influence dielectric properties ofspecific soft tissue layers (e.g. may synergistically influence transferof RF waves into the soft tissue). Repeated muscle contractionaccelerates body metabolism, heats up adjoining soft tissues, stimulatessecretion of several hormones, may change polarity of some soft tissuestructures that influence transfer of RF energy into the soft tissueand/or may be beneficial for body shaping as reducing adipose cellvolume, muscle building, muscle strengthening. Muscle contraction causesmassage of adjoining soft tissue structure and cause massage of the deepsoft tissue layers without affecting the surface of the patient.

Different nerves and soft tissue structures may be stimulated usinginterferential electrotherapy with a medium frequency in the range of500 Hz to 12 kHz or in a more preferred embodiment in the range 500 to 8kHz, in the most preferred embodiment in the range 500 to 6 kHz,creating pulse envelopes with frequencies for stimulation of the nervesand tissues e.g. sympathetic nerves (0.1-5 Hz), parasympathetic nerves(10-150 Hz), motor nerves (10-50 Hz), smooth muscle (0-10 Hz), sensornerves (90-100 Hz), nociceptive fibers (90-150 Hz).

Muscle stimulation may be provided by e.g. intermittent direct currents,alternating currents (medium-frequency and TENS currents), faradiccurrent as a method for multiple stimulation and/or others. Frequency ofthe currents and/or its envelope is typically in the range from 0.1 Hzto 200 Hz in preferred embodiment or from 0.1 Hz to 150 Hz in morepreferred embodiment or from 0.1 to 140 Hz in the most preferredembodiment.

The method of nerve/muscle stimulation by magnetic field may use a peakto peak magnetic flux density on a coil surface at least 0.2 T, 0.4 T,1.5 T, 2 T, at least 3 T, or up to 7 T. The repetition rate may be 1Hz-700 Hz or more preferably 1 Hz-300 Hz or most preferably 1 Hz-200 Hz,with initial or successive treatments lasting several seconds or longer,for example, for at least 5, 10, 30, 60, 120 or 240 seconds, or longer.The pulse width is in the range of tens to hundreds of microseconds.

Stimulation of a patient's soft tissue by magnetic field and/or electricfield may be used with or without contact of such treatment energysource with the patient's surface.

A treatment energy source may also provide another treatment by agenerated magnetic field and/or electric current. Exemplary frequencyranges for individual types of treatment are:

2-10 Hz—endogenous opioid theory—chronic pain management;

60-100 Hz—gate control theory—acute pain management;

120-140 Hz—peripheral pattern theory—subacute pain management;

5 and 150 Hz—fracture healing;

45 Hz—joint mobilization;

2-70 Hz—myostimulation.

RF treatment energy source combined with at least partial musclestimulation may have also other convenient parameters and effects as itis described in U.S. Provisional Application No. 62/340,398 incorporatedherein by reference.

It is an object of the invention to provide an apparatus and method forimproving skin viability, rejuvenation, tightening and body shaping,contouring and/or treatment of other skin and body conditions usingapplication of RF energy and electrical stimulation to soft tissue.

The device may be composed of power supply, control unit, userinterference, and one or more applicators, wherein the at least oneapplicator provides RF therapy and/or electrotherapy. The device mayinclude a cooling mechanism. The patient's skin may be cooled tominimize discomfort and/or health risk, or to make therapy moreeffective and/or faster. Some components of the device may be cooled toprevent them from overheating.

RF (radio frequency) energy may selectively treat different tissuesbased on their impedance and localization. Applied RF field affectstreated soft tissues mainly by a thermal effect. However, the RF fieldmay also influence ions and partially charged molecules in the treatedcells and molecular complexes.

Electrotherapy is founded on the effect where an electric current (a)passes through the body and/or (b) locally changes ion balance and/or(c) changes electric potentials in the soft tissue. The effect ofelectrotherapy may be muscle contraction and/or partial, localionization of a soft tissue. Another effect may be influence formationand/or spreading of nerve stimulation. In some embodimentselectrotherapy may not provide thermal therapy of soft tissue.

According to one embodiment RF energy and electrical stimulation may beused simultaneously or in sequence via one or more energy sources.

In order to improve the treatment effect, electrotherapy may be used inseveral ways: analgesia, tissue regeneration, relaxation, partly tissueionization, muscle building, muscle strengthening and/or others asdescribed below. Combinations of electrotherapy and RF therapy havedesirable effects in soft tissue treatment.

Using electro-stimulation of skeletal muscle fibers and/or other softtissue by using electrotherapy and application of an RF field hasseveral synergistic benefits. Repeated contraction of muscle fibersimproves lymphatic and blood circulation in local and peripheral tissue.Increased blood circulation has a positive effect on homogeneity anddissipation of delivered energy into the targeted tissue. Combinedtherapy (in simultaneous and/or sequential use) minimizes risk ofcreating hot spots and consecutive unwanted soft tissue injury duringthe treatment. Without being bound to the theory, it is believed thatthe increased blood flow in the target soft tissue and/or peripheralsoft tissue has substantial influence on removal of cellulite and/or fattissue.

Another method to reduce adipose cells is skin massaging byelectro-stimulation. This method is based on improving of bloodcirculation and increasing fat metabolism. Improved effects of blood,lymphatic circulation and fat metabolism may be provided by skeletalmuscle stimulation.

Electrotherapy may be provided simultaneously, with some overlay orsequentially, before and/or after application of RF therapy.Electrotherapy and RF therapy may be provided to the same and/or to thedifferent target areas. Electrotherapy and/or RF therapy may be providedby different types of pulses and/or by continual stimulation. Energy ofRF therapy and/or electrotherapy may be modulated in different ways(e.g. shape of the signal and the envelope-curve outlining the signal,polarization of the signal, intensity, frequency, time between one ormore pulses, and/or other forms of modulation.

The advantages of electrotherapy is targeting energy into muscle fibersof a muscle group. Contracting muscle fibers may be used for internalmassage of target and/or adjacent tissue. This massage phenomenon isbeneficial to lymphatic and blood circulation that cause acceleration ofmetabolism. Faster metabolism provides a better treatment result andmore effective treatment, which means a shorter therapy time, and theeffect may be long lasting in comparison with prior art methods.Stimulation of lymphatic and/or blood circulation reduces health riskwhile removing fat and/or cellulite and also improves the therapyresults.

A beneficial effect of the present methods is to treat cells in order toinduce apoptotic death. Due to combined effect of the RF therapy andelectrotherapy and increased blood and lymph circulation, the cells atthe targeted area are treated more homogenously and cells are removedfaster.

The present device has several possible embodiments based on invasiveand/or non-invasive methods, wherein the applicator may also be adaptedto operate in contact or non-contact mode with the skin of the patient.

An applicator includes one or more electrodes. The electrodes may bemodularly connected to the applicator in order to vary the treatmentsurface, distance between electrodes and provide easier, effective,faster and/or safer treatment. Electrodes may be controlled individuallyand/or in a group. Controlling the electrode includes changingparameters of energy: intensity, flux density, time between pulses,shape of signal, type of produced therapy and/or switching on/off anindividual electrode or electrodes.

The applicator and/or electrodes may be created from rigid or flexiblematerial adaptable to curved body surfaces. Transfer of electricaland/or RF energy into the soft tissue and different parts of the patientmay be based on capacitive, inductive and/or resistive energy transfer.

RF therapy provides electromagnetic field which heats soft tissue. Heatis produced as a resistive loss of electromagnetic energy. Warming ofthe tissue is based on impedance characteristics of the tissue. Heatingand/or cooling of the soft tissue is important because the soft tissuedielectric and other parameters (e.g. permittivity, permeability,impedance, conductivity and/or other related dielectric parameters)change with changes in temperature and frequency of appliedelectromagnetic waves. While the conductivity of soft tissue increaseswith temperature, cooling of the soft tissue may result in lesselectrical conductivity. These properties may help with targeting of thedelivered energy into the soft tissue. Heating and/or cooling during,before and/or after treatment may be provided by cooling/heating pads,plates, spacing objects and/or gels. Temperature targeting may differwith various therapies e.g.: neocolagenesis, neoelastogenesis, fatremoval, or protecting of an area.

RF therapy can be applied to the soft tissue in various ways. Thetreatment system can use bipolar electrodes, where electrodes alternatebetween active and return function and where the thermal gradientbeneath the electrodes is almost the same during treatment.

The system may alternatively use monopolar electrodes, where a so-calledreturn electrode has a larger area than the so-called active electrode.The thermal gradient beneath the active electrode is therefore higherthan beneath the return electrode

A unipolar electrode may also optionally be used. During unipolar energydelivery there is one electrode, no grounding pad, and a large field ofRF emitted in an omnidirectional field around a single electrode.

If more than one applicator is used, applicators may be positioned onopposite sides of the patient. A spacer may be positioned between one ormore applicator and the skin of the patient. The electromagnetic wavesmay be transmitted in the range of range 6,765 to 6,795 kHz or 13,553 to13,567 kHz or 26,957 kHz to 27,283 kHz or 40.66 to 40.7 MHz or 433.05 to434.79 MHz or 902 to 928 MHz or 2,400 to 2,500 MHz or 5,725 to 5,875 MHzor 24 to 24.25 GHz or 61 to 61.5 GHz or 122 to 123 GHz or 244 GHz to 246GHz from the applicator into the subcutaneous tissue. The temperature ofthe tissue surface may be increased to about 32-70° C. more preferablyfrom 35-60° C. most preferably from 37-50° C.

Electromagnetic fields used for heating soft tissue may be aradiofrequency field or microwave field, typically in the range of 0.1MHz to 25 GHz. Waves of the RF therapy may be delivered preferably inthe range from 100 kHz to 3,500 kHz or 6,765 to 6,795 kHz or 13,553 to13,567 kHz or 26,957 kHz to T1,283 kHz or 40.66 to 40.7 MHz or 433.05 to434.79 MHz or 902 to 928 MHz or 2,400 to 2,500 MHz or 5,725 to 5,875 MHzor 24 to 24.25 GHz or 61 to 61.5 GHz or 122 to 123 GHz or 244 GHz to 246GHz or optionally at other frequencies as well.

The main effects of electrotherapy are: analgesic, myorelaxation,iontophoresis, and at least partial muscle contraction andanti-edematous effect.

Each of these effects may be achieved by one or more types ofelectrotherapy: galvanic current, pulse direct current and alternatingcurrent.

Galvanic current (or “continuous”) is a current that may have constantintensity and/or a non-zero absolute value of intensity at all times. Itmay be used mostly for iontophoresis, or for trophic stimulation(hyperemic) effect. Galvanic intermittent current may also be used. Thegalvanic component may be about 95% but due to interruption of theoriginally continuous intensity the frequency may reach 5-12 kHz, 5-9kHz, or 5-8 kHz.

Pulse direct current (DC) is of variable intensity but only onepolarity. The basic pulse shape may vary. It includes e.g. diadynamics,rectangular, triangular and exponential pulse of one polarity. Dependingon the frequency and intensity it may have stimulatory, tropic,analgesic, myorelaxation, iontophoresis, at least partial musclecontraction and anti-edematous effects.

In Alternating Current (AC), the basic pulse shape may be rectangular,triangular, harmonic sinusoidal, exponential and/or other shapes and/orcombinations of those mentioned above. It can be alternating, symmetricand/or asymmetric. Use of alternating currents in contact electrotherapyimplies much lower stress on the tissue under the electrode. For thesetypes of currents the capacitive component of skin resistance isinvolved, so that these currents are very well tolerated by patients.

AC therapies may be differentiated into five subtypes: TENS, Classic(four-pole) Interference, Two-pole Interference, Isoplanar Interferenceand Dipole Vector Field. The modularity of period and shape of theenergy may vary.

Using interferential electrotherapy different nerves and soft tissuestructures can be stimulated by a medium frequency of 500 Hz to 12 kHz,500 to 8 kHz, or 500 to 6 kHz, creating pulse envelopes with frequenciesfor stimulation of nerves and tissues e.g. sympathetic nerves (0.1-5Hz), parasympathetic nerves (10-150 Hz), motor nerves (10-50 Hz), smoothmuscle (0-10 Hz), sensor nerves (90-100 Hz) nociceptive fibres (90-150Hz).

Electrotherapy may provide stimulus with currents of frequency in therange from 0 Hz to 12 kHz, 0 Hz to 8 kHz or 0 Hz to 6 kHz.

Time between two pulses and/or time between two band of pulses (burst)may be variable depending on a function and adjustable with the type oftherapy and type of the patient.

Analgesic effects may be achieved. The analgesia is beneficial duringthe treatment of high dose RF therapy and in order to make therapy morecomfortable. Some highly sensitive individuals may feel discomfortand/or pain during the treatment therapy, even if the treatment runswithin the range of safe threshold limits. Another beneficial effect isthat if patient feels pain, muscle tone usually increases in theaffected area. Long lasting muscle contraction may cause pain in themuscle for several days and/or damage muscle fibers. Long lasting musclecontraction is therefore not only uncomfortable, but it also may affectthe blood and lymph circulation. Whereas the treatment may be improvedby sufficient fluid circulation during and/or after the treatment.

In electrotherapy, it is important to understand the modulating factorsinfluencing the perception and transfer of the painful stimulus. Ananalgesic effect may occur by stimulation of type A nerve fibres byfrequency 50-150 Hz and/or type C-thin fibers by frequency 2-8 Hz.

For most analgesic effects it is possible to choose several types ofcurrents e.g. diadynamic current, currents changing in long lastingperiod, bipolar amplitude modulated medium frequency currents, TENSand/or other interferential currents (in range of 0.1-1 kHz).Frequencies of the currents are described above.

A myorelaxation effect may be achieved. Myorelaxation effects cause atleast a partial decrease in muscle fiber tone. Myo re laxative effectsmay be beneficial for improving homogeneity of delivered RF therapyand/or faster regeneration of the soft tissue and/or a more comfortabletherapy. Long lasting permanent muscle contraction may slow body fluidcirculation e.g. lymph and blood circulation, that has a therapy effect.Long lasting muscle contraction is also very exhausting. For betterresults, a comfortable therapy is needed because the psychological stateof the patient has influence on human metabolism.

In order to provide myorelaxation amplitude modulated medium frequencycurrents, a frequency of the pulse envelope in range 0-300 Hz, 0-200 Hzor 0-150 Hz may be used. It is also possible to use TENS and/or others.

According to another embodiment muscle fibers stimulation may beachieved. Muscle stimulation increases muscle tone, musclestrengthening, restoration of feeling the muscle, relaxation of themusculature and/or stretching musculature.

Muscle stimulation increases a blood flow and lymph circulation. It mayimprove removing of treated cells and/or prevent creation of hot spots.Moreover internal massage stimulation of adjoining tissues improveshomogeneity of tissue and dispersing of the delivered energy. During fatremoval, the RF therapy may change the structure of the fat tissue. Themuscle fiber stimulation may provide internal massage, which may be forobese patient more effective than classical massage.

Muscle stimulation may be provided by e.g. intermittent direct currents,alternating currents (medium-frequency and TENS currents), faradiccurrent as a method for multiple stimulation and/or others. Frequency ofthe currents and/or its envelope is typically in the range from 0.1 Hzto 200 Hz, 0.1 Hz to 150 Hz, or from 0.1 to 140 Hz.

According to still another embodiment the electrostimulation may beprovided in a combined manner where various treatments with variouseffects may be achieved. As an illustrative example, the electromagneticstimulation may be dosed in trains where the first train of stimulationmay achieve a different effect than second or other successive train ofstimulation. Therefore, the treatment may provide muscle fibersstimulation followed by relaxation, during continual or pulsedradiofrequency thermal heating.

Current density of electrotherapy for nongalvanic current may bepreferably lower than 10 mA·m⁻², lower than 5 mA·m⁻², lower than 4mA·m⁻², or lower than 1 mA·m⁻². Galvanic current may be preferably lowerthan 1 mA·m⁻², lower than 0.5 mA·m⁻², or lower than 0.1 mA·m⁻².

Energy flux density of RF therapy is preferably in the range of 0.01mW·mm⁻² to 10,000 mW·mm⁻², 0.1 mW·mm⁻² to 5,000 mW·mm⁻², or 0.5 mW·mm⁻²to 1,000 mW·mm⁻².

The source of RF waves and/or electrotherapy may be at least oneelectrode. When the only one electrode is applied, the electrode mayserve as both the RF and the electrotherapeutic source. The therapiesmay be applied together, successively or in overlap. The electrode mayconsist of electrode itself and coating, wherein the coating may notcover the whole surface of electrode.

In FIG. 29 the system has a power supply, control unit, userinterference, one or more sensors and an applicator providing RF and anapplicator providing electrotherapy. However, there may be only oneapplicator providing both RF therapy and electrotherapy.

The power supply may be managed by the control unit. Regulation ofdelivered energy may be controlled by the control unit. The control unitmay also evaluate feedback information from one or more sensors, and/ortreatment parameters from the user interface and/or by a predeterminedprotocol. The control unit may contain one or more cooperating units.Control and cooperation units are elements of the device influencetreatment parameters of the therapy (e.g. therapy time, amount ofdelivered energy, burst timing, frequency of provided energy, intensityof energy, controlling switching on/off different group of electrode/s,shape of the pulses and others). The one or more control units may belocated in the applicator and/or one or more control units may bylocated out of the applicator (e.g. in the case of the device).

The user interface may allow operator to change and/or set up thetreatment parameters. Treatment parameters may be set up in the range ofsafe thresholds (e.g. individually for each therapy). Thresholdtreatment parameters may be operatively changed depending on therapyand/or detected parameters from the feedback sensors. Safe dosage of thedelivered energy and/or dependence of each parameter may be pre-set.Course of treatments may be provided by computer and/or operator.Treatment may be guided manually, automatically and/orsemi-automatically where some of the treatment parameters are set upmanually A computer may change inappropriately set up parameters and/oralert the operator.

If treatment parameters are evaluated as safe, therapy may start. It maybe possible to adjust parameters of the therapy or add therapy typese.g. galvanic current, pulse direct current and alternating current.Treatment may be time limited and stopped if values of one or moredetected parameters reach their limits e.g. time, time and temperature.Safe thresholds may be dependent on treated body part or target area.The soft tissue to be treated may be classified by e.g. ultrasound, orfrom the information of backscattered radiofrequency wave.

The method may be carried out automatically or semi-automaticallysubstantially without human control or can be carried only with humancontrol, without or with any predetermined parameters (includingsequences, shape of delivered pulses etc.).

The device may have one or more sensors providing feedback informationin order to improve efficiency of the treatment and reduce health risk.Based on feedback treatment information, therapy parameters may bemanually or automatically or semi-automatically optimized or therapy maybe interrupted. Sensors also may control some properties of the device.The device may contain different types of sensors for monitoring deviceparameters and/or monitoring of body biological, physical, chemicaland/or other parameters (e.g. a reactive sensor; an electrochemicalsensor; a biosensor; a biochemical sensor; a temperature sensor; asensor for measuring distance of the applicator from the patient skin,from some area of the patient soft tissue and/or from the otherapplicator; a sorption sensor; a pH sensor; a voltage sensor; a detectorof moving velocity and/or change of position; photo sensor; sensormeasuring viscosity; a camera; a sensor measuring fluorescence of thepatient surface; a sound detector; a current sensor; sensor formeasuring of specific heat capacity of human/animal tissue; sensor formeasuring impedance; permittivity; conductivity; susceptibility and/orany suitable sensor or sensors measuring biological parameters and/orcombination thereof e.g.: sensor for measuring dermal tensile forces;sensor for measuring the activity of the muscle; a muscle contractionforces; skin elasticity). The device may also include at least onecontact sensor for monitoring of applicator and/or electrode or moreelectrodes contact with body surface.

Each sensor may provide feedback information to control energy deliveryand/or other treatment parameters to improve efficiency of a treatmentand/or reduce health risk and/or discomfort during the treatment. Thetreatment therapy parameters may be manually or automatically orsemi-automatically optimized based on feedback information. If thetreatment parameters are evaluated as not-safe, the treatment is stoppedor the treatment parameters may be changed.

Treatment therapy may be guided with partially or fully predeterminedtreatment protocol or without predetermined treatment protocol. With thetreatment carried automatically (allowing treatment without operator),semi-automatically and/or by operator. The operator may set up and/oradjust any parameter of treatment therapy.

In one embodiment applicator may be stationary adjacent to the patientsurface. In another embodiment moving the applicator or multipleapplicators may be advantageous.

Moving with the applicator may be provided automatically (providedwithout operator), semi-automatically (e.g. mechanical arm) and/ormanually by operator.

Movement of the applicator may be straightforward, curvilinear,rotational, changing distance from the patient surface and/or may createsome pattern. A plurality of applicators may move in a synchronized,randomized and/or independent manner. The applicator may beautomatically and/or manually moved and rotate along every Cartesiancoordinate.

The one or more applicators may be placed or moved in a chosen geometrypattern comprising of e.g. linear, wavy circular, elliptical, zigzag,polygonal, oval, irregular, curvilinear or their combination. Thismoving may be replicated by placing one or more stationary applicatorsin position and switching over relevant electrodes, without moving theapplicators.

The same possible movements of one or more applicators may be consideredfor moving the electrodes.

According another embodiment the device may provide treatment by plasmaand/or by combination of plasma with another treatment energy sourcee.g. RF treatment energy source. Plasma may be also supplemented withsubstances enhancing generation of plasma and/or treatment results asdescribed in U.S. Provisional Application No. 62/409,665 incorporatedherein by reference.

According to another embodiment treatment may be further influenced andimproved by an active agent substance (e.g.: gas, gel, liquid,suspension) that may make treatment more comfortable (e.g. lesspainful), faster, treatment may have better results and/or may maketreatment more targeted. Active agent may be supplied before duringand/or after treatment automatically by the device itself and/or by aperson supervising the treatment.

In addition, the supplied mixture (e.g. green tea extract) may includeother substances. Application of the substance and/or mixture of thesubstances may provide patient with a more comfort and/or improve thetreatment effect.

In one embodiment, the substance may modulate normal metabolism and/orbasal metabolism rate of the patient's body. It may provide accelerationto the metabolism related to the apoptotic cells. Such substances mayinclude alkaloids (e.g. xanthines), antithyroid agents, metformin,octreotide and a like.

In another embodiment, the substance may modulate efferocytosis, whichis the process by which dying cells are removed by phagocytic cells.This may provide acceleration and improvement in the dead cells removal.Such substance may include prostaglandins and their analogues, modifiedlipids (e.g. lysophosphatidylserine, lipoxins, resolvins, protectinsand/or maresins), lipoprotein lipase inhibitors, nitric oxide secretionstimulators, alkaloids (e.g. xanthines), aspirin, antioxidants (e.g.ascorbic acid), derivatives of carbohydrates and a like.

In another embodiment, the substance may modulate lipolysis rate. Incase of application of electromagnetic energy to the adipocytes it mayprovide another way of removal of the adipose cells, which may beindependent from the treatment method. Such substances may includeterpens (e.g. forskolin), catecholamins, hormons (e.g. leptin, growthhormone and/or testosterone), alkaloids (e.g. synephrin),phosphodiesterase inhibitors (e.g. xanthins), polyphenols, peptides(e.g. natriuretic peptides), aminoacids and a like.

In another embodiment, the substance may modulate hydration of thepatient. Such substances and/or mixtures may include xanthines, lactatedRinger's solution, physiological saline solution and a like.

In another embodiment, the substance may modulate circulatory system ofthe patient. This may provide the higher rate of blood circulation,which may result in faster cooling rate of the skin. Such substances mayinclude catecholamines, alkaloids (e.g. xanthins), flavanols and a like.

In another embodiment, the substance may induce the reversible decreaseor absence of sensation in the specific part of the patient's body. Thismay provide a certain level of comfort to heat-sensitive patient. Suchsubstances may include lidocaine, benzocaine, menthol and a like.

In another embodiment, the substance may shield the electromagneticradiation from the patient's body. This effect may be used forprotection of sensitive parts of the human body. Such substances mayinclude mixture containing metal nanoparticles, mixture containingpolymer particles and a like.

In another embodiment, the substance may modulate the effect theelectromagnetic radiation applied on the patient's body. This mayaccelerate removal of the desired tissue, for example by heating of thetissue and/or increasing the effect of the applied radiations. Suchsubstances may include carotens, chlorophylls, flavanols and a like.

Substances may be used singularly or in various combinations with atleast one other suitable substance. For example, lidocain providinglocal anesthesia may be combined with prilocaine to provide improvedeffect. The substance and/or mixture of the substances may beadministered at different times during the tissue treatment. It may beadministered before the treatment, during the treatment and after thetreatment.

In another embodiment, the substance may be administered over seconds,hours or even days to accumulate in the desired tissue. The subsequentapplication of the electromagnetic radiation may modulate the action ofthe accumulated substance and/or be modulated by the action of thesubstance. According the example of this embodiment, a chromophore maybe accumulated in the treated tissue, such as adipocytes, before thetreatment. The chromophore may then absorb electromagnetic radiation andheat the tissue nearby.

Such active agents may influence the treatment therapy as described inU.S. Provisional Application No. 62/331,060 incorporated herein byreference.

Connection transferring high frequency (above 100 kHz) signal betweenindividual parts of the device (e.g. connecting of the applicator orother devices) may be provided by special magnetic connectiontransferring high frequency signal or high frequency signal and data.

Such magnetic connection may be an easier, faster way to connect highfrequency sources and may have longer durability than connector based onprincipal sinking or latching one part of connector to another part ofconnector.

One of possible embodiment of such a connection is illustrated in theFIG. 9A, FIG. 9B and FIG. 9C. FIG. 9A illustrates both parts of theconnector connecting together a lower part of the connector and an upperpart of the connector as depicted in FIG. 9B and FIG. 9C, respectively.

Connector includes supply cables 901 a and 901 b attached to conductiveplates 902 a and 902 b. The upper and/or the lower part of the connectorare attached to permanent or temporary magnet(s) 903 a, 903 b in orderto provide connections between both parts. High frequency signals may betransferred between the lower and the upper connector part by aconductive connecting member(s) 904 a and 904 b rising from the lowerand/or the upper part of the connector.

Conductive plates 902 a and 902 b may be replaced by more conductiveelements located in the lower and the upper part of the connector.

The number of conductive connecting members 904, their size and shapemay be variable. According one embodiment connecting members 904 may beformed as pins or cylinders (see FIG. 9). Diameter of such cylinder maybe in range 0.1 mm to 5 cm or 0.1 mm to 1 cm or in range 0.1 mm to 5 mm.According another embodiment, cylinders may be replaced by conductivering, Cylinders with at least partial spherical objects on one endand/or other shapes of conductive connecting member 904. Conductiveconnecting member(s) 904 is connected with supply cable(s) 901 byconductive plate(s) 901, directly or through other conductive orsemi-conductive members. When connector is connected at least oneconductive connecting member 904 is in contact with both parts of theconnector. Conductive connecting member 904 may be from conductive orsemi-conductive material(s).

High frequency signal is mostly transferred on the surface of theconductive connecting member 904. In order to minimize overheating ofmagnet(s) 903 providing attaching of both connector parts, and also inorder to minimize inducting of electric or electromagnetic field actingagainst transferred high frequency signal in conductive connectingmember(s) 904, conductive connecting members 904 are placed around thecentral magnet(s) 903 as it is illustrated in the FIG. 9.

Described type of high frequency connector may be used also as coaxialcable for information transfer.

According to another embodiment the method and the device describedabove may be used in combination with a method and a device of lighttherapy, described below. Such light method and the device may beimplement in the applicator using vacuum and RF and/or may be used asseparated applicator providing at least light therapy treatment as it isdescribed below.

Referring now to FIG. 10, in one embodiment the device includes base1001, handheld applicator 1014, and/or scanning unit 1002. Handheldapplicator 1014 may be used for delivery of light energy from the base1001 to the scanning device 1002. Base 1001 may include central controlunit 1004, user interface 1005, energy generator 1006 and/or calibrationunit 1007.

The central control unit 1004 may change the treatment parameters and/orcontrol other parts of the device coupled to it. The method of operationmay include the central control unit 1004 communicating with userinterface 1005, energy generator 1006, power supply 1003 and/orcalibration unit 1007. The central control unit 1004 may alsocommunicate with a scanning power supply 1008, scanning optics 1011,scanning control unit 1009, movement assembly 1010 and/or transmissionelement 1012 located in the scanning unit 1002.

The device may include one or more energy generators. Energy generator1006 may comprise, for example, a light emitting diode, a laser emittingdiode, a flashlamp, a tungsten lamp, an incandescent lamp, a mercuryarc, or any other light or energy source known in the art. Energygenerator 1006 may generate coherent, incoherent, depolarized and/orpolarized light. Coherent monochromatic light may include any type oflaser, for example a chemical laser, a dye laser, a free-electron laser,a gas dynamic laser, a gas laser (for example an argon laser or carbondioxide laser), an ion laser, a metal-vapor laser (for example a goldvapor laser and/or a copper vapor laser), a quantum well laser, a diodelaser (for example comprising GaAs, AlGaSbAs, InGaAsP/InPm InGaAs),and/or a solid state laser (for example a ruby laser, a Nd:YAG laser, aNdCr:YAG laser, a Er:YAG laser, an Er:glass laser, a CTH:YAG laser, aNd:YLF laser, a Nd:YVO4 laser, a Nd:YCOB laser, a Nd:Glass laser, aTi:sapphire laser, a Tm:YAG laser, a Ho:YAG laser or an Er,Cr:YSGGlaser). The energy generator may be cooled by air and/or water. Methodsof operation may include energy generator 1006 communicating with userinterface 1005, calibration unit 1007 and/or central control unit 1004.Energy generator 1006 may also communicate with scanning optics 1011,typically by providing the generated energy (for example light).

User interface 1005 may include an LCD panel or other suitableelectronic display. User interface 1005 may be located on the base 1001,handheld applicator 1014, and/or scanning unit 1002. User interface 1005may communicate with energy generator 1006, central control unit 1004and/or calibration unit 1007. User interface 1005 may also communicatewith scanning optics 1011 and scanning power supply 1008 located in thescanning unit 1002.

Calibration unit 1007 may be controlled by central control unit 1004.Calibration unit 1007 may check the stability of the output and/or thewavelength or wavelengths of the energy generator 1006. In case ofinstability, calibration unit 1007 may provide one or more humanperceptible signals to the operator. The calibration unit 1007 may alsoprovide information to the central control unit 1006 which may adjust orcorrect one or more parameters of energy generator 1006. Calibrationunit 1007 may check input or output parameters of the energy thescanning optics 1011, located in the scanning unit 1002. Methods ofoperation may include the calibration unit 1007 communicating with userinterface 1005 and/or central control unit 1004.

Calibration unit 1007, energy generator 1006 and/or user interface 1005may be positioned in or on base 1001, handheld applicator 1014 orscanning unit 1002.

Embodiments of devices of the present invention may include one or morescanning units 1002 which may include scanning power supply 1008,scanning control unit 1009, movement assembly 1010, scanning optics1011, sensor 1013 and/or transmission element 1012. In some embodiments,scanning unit 1002 may provide movement of the energy spot by changingone or more characteristics of the energy beam, including but notlimited to the direction or intensity of the energy beam. A method oftreatment may include control of the scanning unit 1002 through centralcontrol unit 1004 by the user interface 1005. The scanning unit 1002 mayin some embodiments be positioned on a manually or automaticallyadjustable arm. The scanning unit may be tilted to any angle withrespect to the tissue. During some embodiments of treatments using thesystem of the present invention, the scanning unit may remain in a setposition and the energy spot may be moved by the optics inside thescanning unit. In some embodiments, the scanning unit may movecontinuously or discontinuously over the body and provide treatment byone or more treatment patterns.

The scanning power supply 1008 may provide electrical power tocomponents of the present invention, including but not limited toscanning optics 1011, scanning control unit 1009, movement assembly 1010and/or transmission element 1012. The scanning power supply may comprisea battery and/or a power grid. The scanning power supply 1008 may becoupled to power supply 1003. Alternatively, electrical power may besupplied from the power supply 1003 directly to some or all mentionedparts by the scanning power supply 1008.

The scanning optics 1011 may include one or more collimators, lightdeflecting elements (e.g. deflecting mirrors), focusing/defocusingelements (e.g. lenses) and/or filters to eliminate certain wavelengthsof light. The scanning optics 1011 may be controlled according to anoperator's needs through user interface 1005. The scanning optics 1011may be controlled by central control unit 1004 and/or scanning controlunit 1009. Both central control unit 1004 and scanning control unit 1009may control one or parameters of the scanning optics, particularly ofone or more deflecting elements. Parameters controlled may comprise thespeed of movement of one deflecting element, which may be in the rangeof 0.01 mm/s to 500 mm/s, more preferably in the range of 0.05 mm/s to200 mm/s, most preferably in the range of 0.1 mm/s to 150 mm/s.

Scanning control unit 1009 may control one or more treatment parameters.The scanning control unit 1009 may communicate with central control unit1004, scanning power supply 1008, movement assembly 1010 and/or scanningoptics 1011. The scanning control unit 1009 may be controlled throughcentral control unit 1004 according to the operator's needs selected onthe user interface 1005, or the scanning unit 1002 may include anotheruser interface. In one embodiment, one or more functions of the scanningcontrol unit 1009 may be assumed and/or overridden by central controlunit 1004.

Movement assembly 1010 may cause movement of one or more energy spots ontreated tissue. The movement assembly 1010 may communicate with scanningoptics 1011 and cause movement of one or more light deflecting elements,which may be parts of the scanning optics 1011. The movement assembly1010 may be controlled by central control unit 1004 and/or scanningcontrol unit 1009. The movement assembly 1010 may also communicate withtransmission element 1012. The movement assembly 1010 may comprise oneor more motors and/or actuators. The movement assembly 1010 may provideangular and/or linear movement to the light deflecting elements of thescanning optics 1011. In some embodiments, the movement assembly 1010may provide movement to the transmission element 1012.

Some energy may leave the scanning unit 1002 through the transmissionelement 1012. Transmission element 1012 may comprise one or moreelements made from translucent materials, e.g. from glass, diamond,sapphire or transparent plastic. Transmission element 1012 may beconnected to the movement assembly 1010, which may control focusing,defocusing, vertical or curvilinear movement or tilting of thetransmission element 1012. Vertical movement of the transmission element1012 may be used to change the energy spot size. Horizontal movement ofthe transmission element 1012 provided by movement assembly 1010 may beused to change one or more parameters of a light or energy beamdelivered to the tissue. When the transmission element includes moreelements made from translucent material, horizontal movement may berepresented by movement of a separate element into the pathway to changeone or more characteristics of the energy provided to tissue (e.g.focus, power output). Some disclosed configurations may be used forapplication of more than one energy beam to the tissue. Someconfigurations may include a scanning unit comprising more than onetransmission elements 1012. In some embodiments, the one or moretransmission elements 1012 are optionally covered by coverings, forexample lens caps, controlled by movement assembly 1010.

The scanning unit 1002 and/or handheld applicator 1014 may include oneor more sensors 1013, e.g. an ultrasound sensor, a gyroscope, a Hallsensor, a thermographic camera and/or an IR temperature sensor.

Additionally, the energy generator 1006 may be part of an energygenerating module which can be removed from the base 1001, the handheldapplicator 1014 or the scanning unit 1002. User may vary the wavelengthof the energy by adding, replacing or removing at least one or moreenergy generating modules. The energy generating module may include atleast one energy generator 1006 together or without calibration unit1007 and identifier, which may communicate with central control unit1009 and user interface 1005. Identifier may be an RFID tag, sequence ofspecific electrical pulses, measuring of magnetic field in/near theconnection that may be specific for individual type of the energygenerating module. After connection of the energy generating unit to thedevice, central control unit 1009 may identify the energy generatingunit by the identifier.

The adjustable arm may be adjusted manually by user or automatically. Inone embodiment, handheld applicator 1014 may be coupled to the scanningunit 1002 through adjustable arm including wave guide.

FIG. 11A shows an exemplary handheld applicator 1014, comprising body1103, light waveguide 1101, sensor 1102 and/or translucent element 1104.Flexible light waveguide 1105 may connect the handheld applicator 1014with the base 1001. Light waveguide 1101 may be encased in the body 1103and may provide an energy path where the energy path leaves the handheldapplicator 1014 through the translucent element 1104. In someembodiments, translucent element 1104 is similar to transmission element1012 of the scanning unit 1002.

FIG. 11B shows handheld applicator 1014 coupled to a zooming assemblyincluding lens 1110, focusing mechanism 1109, spacer 1108 and emitters1106. The handheld applicator 1014 may control the energy spot size bymanipulation of the lens 1110. Lens 1110 may be moved by focusingmechanism 1109, which may comprise a screwing mechanism. The zoomingassembly may include spacer 1108, which may have length (i.e. from thetissue to the lowest lens position marked as 1111) in a range of 0.05 cmto 50 cm, more preferably in the range of 0.1 cm to 35 cm, mostpreferably in the range of 0.15 to 10 cm. The zooming assembly may alsoinclude focusing mechanism 1109.

A handheld applicator of the present invention may include one or moresensors 1102 for gathering measurements from the surrounding environmentand/or from the one or more emitters 1106. Emitters 1106 (e.g. magnet),located on scanning unit 1002, may provide information to sensor 1102(e.g. a Hall sensor). Based on the emitted and recognized information,the central control unit may identify particular types of handheldapplicators and scanning units. Methods of recognizing the type orconfiguration of the handheld applicator may alternatively include RFID,data communication or other methods known in the art. The centralcontrol unit may enable, disable, or adjust one or more treatmentparameters according to the handheld applicator recognized and thescanning unit recognized. Also, the central control unit 1004 may limittreatment parameters according to the recognized zooming assemblyincluded with the handheld applicator and/or scanning unit 1002. Sensors1102 together with emitter 1106 may also ensure correct attachment ofthe handheld applicator 1014 with scanning unit 1002 and/or the zoomingassembly. Methods of operation may therefore include any humanperceptible signal and/or ceasing of treatment (for example by shuttingdown the energy source) when the attached handheld device or itssettings are not correct.

Handheld applicator 1014 may be connected to the scanning unit 1002 viaan attaching mechanism. FIG. 12A shows handheld applicator 1014separated from scanning unit 1002. Handheld applicator 1014 as shownincludes light waveguide 1101 guiding the light (represented by arrow1208), encased in the handheld applicator body 1103. In someembodiments, handheld applicator 1014 contains at least one pin 1201. Inthe exemplary embodiment, the handheld applicator includes two pins1201. The exemplary partial view of scanning unit 1002 includes recesses1202 for insertion of pins 1201, connector 1203, sealing element 1204,at least one movement element 1205 (e.g. a spring), scanning lightwaveguide 1206, and scanning optics 1011. Movement element 1205 (e.g.spring) may be placed in a dust-proof cylinder.

FIG. 12B shows the handheld applicator 1014 connected to the scanningunit 1002 by connector 1203. The sealing element 1204 may be movedinside the scanning unit 1002 adjacent and/or in direct contact withscanning light waveguide 1206. As a result, the sealing element 1204 ispart of the newly created light wave path including light waveguide1101, translucent element 1104, sealing element 1204 and scanning lightwaveguide 1206. Light 1208 may be transmitted through the newly createdwave path of the scanning optics 1011. Movement of the sealing element1204 is controlled by movement element 1205 (shown as compressedsprings). Alternatively, the movement elements 1205 may move the sealingelement 1204 aside from the light waveguide.

The handheld applicator is secured in the connected position shown inFIG. 12B by insertion of the pins 1201 into the recesses 1202 creatinglocked pins 1207. In the exemplary embodiment, handheld applicator 1014may be rotated during the insertion into the scanning unit 1002 untilthe pins 1201 mate with the recesses 1202. During release, rotation ofthe handheld applicator in the opposite direction may loosen the lockedpins 1207 and the movement elements 1205 may provide assisted release ofthe handheld applicator 1014 from the scanning unit 1002. Alternatively,the handheld applicator 1014 may be secured to scanning unit 1002 byother mechanisms including magnetic force, electromagnets, friction,latching or any other suitable connection method known in the art.

The sealing element 1204 may comprise for example glass, diamond,sapphire or plastic tightly positioned in the connector 1203 in thedust-proof cylinder. The sealing element 1204 may provide a dust-proofbarrier to the scanning unit 1002. Because the sealing element 1204 isfixed in place when the handheld applicator 1014 and scanning unit 1002are connected, the sealing element may prevent transfer of anycontamination and/or dust into the scanning unit 1002.

Devices and methods of the present invention may provide distancecontrol. Distance control may be used to maintain a predetermineddistance between the treated tissue and scanning unit 1002 and/orhandheld applicator 1014. In an exemplary embodiment, the distance maybe measured by sound reflection, for example using an ultrasonictransmitter and detector placed on and scanning unit 1002 and/orhandheld applicator 1014. Measured distance may be provided to thecentral control unit 1004, which may change one or more treatmentparameters according to measured distance. The ultrasound or otherdistance sensor may also measure the temperature of the treated tissue,and the central control unit 1004 may change one or more treatmentparameters according to the measured temperature.

Temperature of the treated tissue may be measured by a thermographiccamera and/or an IR temperature sensor. The measured temperature may becommunicated to the central control unit 1004, which may then change oneor more treatment parameters according to measured temperature of thetreated tissue. Sensors measuring temperature may measure thetemperature as a relative measurement, for example as a differencebetween the temperature recorded at the beginning of the treatment andthe temperature recorded during the treatment. The sensor may alsocommunicate with calibration unit 1007 and provide values of theabsolute temperature of the treated tissue.

A method of treatment may include treatment of one or more treatmentareas using one or more treatment patterns. Treatment of the treatmentarea using one or more treatment patterns may be repeated more than onetime. The treatment area may be defined as an area where the energy spotis moved during a treatment session, together with adjacent tissue.Treatment patterns may be defined as tissue surface paths followed bythe energy spot on the treatment area during one treatment cycle.

Methods of treatment according to the present invention may includefollowing steps: choosing of the body part to be treated; mapping thetissue surface using one or more sensors; proposing and modifying theshape and dimensions of one or more treatment areas; selection of theshape and dimensions of one or more treatment patterns; setting ofthreshold values of treatment parameters; setting of threshold ranges;choosing a treatment mode; transferring energy to the tissue; measuringtreatment parameters and/or tissue characteristics (e.g. color, shapeand/or depth); changing one or more treatment parameters or thresholdsbased on measured characteristics; and returning one or more elements ofinformation as a result of the treatment.

The order of the steps may vary. In some embodiments, one or more of thesteps may be omitted or repeated.

Body parts to be treated may be chosen by the patient, the operatorand/or the device. The patient and/or operator may choose the body partto be treated for aesthetic or medical reasons. Devices may choose thebody part to be treated according to information received from one ormore sensors. For example, the ultrasound sensor may provide informationabout the thickness of adipose tissue, or a camera may provideinformation about presence of aesthetic problems (for examplecellulite).

Mapping of tissue problems may be provided by camera and/or ultrasoundsensor. In case of camera, a tissue problem may be recognized bycomparing the colors observed in the treatment area with the colors ofcorresponding reference tissue. In the case of an ultrasonic sensor,tissue problems may be recognized by comparing the parameters (e.g.amplitude, frequency, period and/or reflection angle) of reflectedmechanical waves from the treatment area with the parameters ofreflected waves from a reference tissue area. Reference tissue areas maybe an untreated tissue area chosen by the operator and/or device. Colorand/or parameters of reflected mechanical waves may be measured beforeand/or after the mapping. The color and/or parameters of the referencetissue may be measured during the mapping by the same sensor and/or adifferent sensor.

In some embodiments, the shape and dimensions of the treatment area maybe selected separately. Shapes may be selected from a predefined set ofshapes, or shapes may be created by the operator and/or device.Additionally, shapes may be proposed by device according to the chosenbody part. The shape of the treatment pattern may be created accordingto an image of the tissue problem captured by a camera. After selectinga shape, in some embodiments the shape may be further modified by theoperator and/or the patient by dividing the shape into a plurality ofsegments (e.g. smaller surface partitions and/or borderlines), or byconverting the to another shape. The creation of a new shape,modification of one or more dimensions, division of created shapesand/or movement of segments may be executed using the user interface1006. Dimensions of the treatment area may be in the range of 1×1 cm to180×180 cm and may have a total area from 1 cm2 to 32,400 cm2, 15,000cm2, 10,000 cm2 or 2,500 cm2. Dimensions of the treatment pattern may bein the range of 0.01 cm2 to 5,000 cm2 or 0.1 cm2 to 2,000 cm2 or 1 cm2to 500 cm2.

Examples of treatment patterns on the tissue surface are shown in FIG.13, and include linear horizontal 1301, linear vertical 1302, lineardiagonal 1303, circular 1304, rectangular 1305, spiral 1306, zigzag1307, tooth-like 1308 and/or S-shape 1309. Treatment patterns may bedelivered in defined points and/or intervals, as shown in patterns 1310and 1311. Alternatively, the treatment patterns may be implementedbeneath the surface of the tissue.

FIG. 14A shows treatment area 1401 with treatment pattern 1402.Treatment pattern 1402 is shown as a large surface pattern, which may beadvantageous in areas of tissue free from any substantial unevenness.FIG. 14B shows treatment area 1401 with uneven region 1403 and threeoverlapping treatment patterns 1402 surrounding the uneven region 1403.

Methods of setting threshold values may include choosing one or morethreshold values of one or more treatment parameters, and using thosethreshold values to determining values for other treatment parameters.Threshold values may include, for example, the surface temperature ofthe treated tissue. Other relevant threshold values include, but are notlimited to, the distance between the tissue and the scanning unit orhandheld applicator, the total energy output to at least part of thetreated tissue area, the energy flux transferred to at least part of thetreatment area, and the scanning speed of the scanning unit 1002 and/orhandheld applicator 1014. Treatment methods of the present invention mayinclude the steps of increasing one or more threshold values until thepatient and/or operator stops the increase. During the increase of thethreshold value, the central control unit 1004 may in some embodimentsadapt at least one other treatment parameter based on the increasingthreshold value. The threshold value may be set before treatment or itmay be changed during treatment according to one or more parametersmeasured by sensor or sensors 1013 (e.g. distance and/or temperature ofthe treated tissue). When the one or more threshold values of treatmentparameters are set, other treatment parameters may be modified by thedevice.

Setting of threshold ranges may include setting of one or moretolerances around a threshold value. Threshold tolerances of the presentinvention may be about 25%, more preferably 20%, even more preferablyabout 15%, most preferably 10% surrounding the threshold value. Methodsof the present invention may include setting tolerances for othertreatment parameters which have no set threshold value. Such tolerancesmay promote homogeneity of treatment.

Selection of treatment modes may include the selection of a treatmentprovided by scanning unit 1002 and/or manual treatment provided byhandheld applicator 1014. Large, smooth treatment areas may be treatedby using scanning unit 1002, while uneven treatment areas may be treatedusing handheld applicator 1014. Scanning unit 1002 may also be used fortreatment of uneven treatment areas, because the device may includeadjustment of treatment parameters according to other steps of themethod. In some embodiments, it is possible to combine the use ofscanning unit 1002 and handheld applicator 1014. For example, treatmentpattern 1402 on FIG. 14A may be provided by scanning unit 1002, whiletreatment patterns 1402 on FIG. 14B may be provided by a handheldapplicator 1014. The operator may use the scanning unit for treatment oflarge or smooth areas of the tissue, while the handheld applicator maybe used for treatment of the areas not treated by the scanning unit.Switching from the handheld applicator to the more effective scanningunit by connecting the former to the latter provides the operator aversatile device for complex treatments. Both modes of treatment may beprovided by one device.

Transfer of energy to the tissue may include irradiation of the tissuewith light, Also, in some embodiments, a camera may provide informationabout the position of the energy spot on the surface of the tissue.

Measuring of treatment parameters and/or characteristics of a tissueproblem may include measurements provided by one or more sensors 1013.Treatment parameters may be measured continuously or in discrete timeintervals. In some embodiments, methods of the present invention includeprocessing the measurement, for example by transmitting the measurementsfrom the one or more sensors 1013 to the central control unit 1004.Sensor 1013 may measure a treatment parameter with a set threshold valueand/or threshold range. Measurement of the tissue temperature may bedone by temperature sensor and measured tissue temperature may becommunicated to the central control unit 1004. Measurements ofcharacteristics of the tissue problem may include measurement of itscolor, shape, depth and/or temperature on the edge of the tissueproblem. Characteristics of the tissue problem may be measured using acamera and/or ultrasonic sensor similarly to methods used in mapping thecolor irregularity.

In response to measured values of treatment parameters, a controller ofthe present invention may select from a set of options includingcontinuing treatment, providing a human perceptible signal, setting anew threshold value and/or threshold range, ceasing treatment, oradjusting one or more treatment parameters to a set threshold in orderto be in the range. For example, when the temperature of the treatedtissue is out of threshold temperature range, the central control unit1004 may cease the energy transfer and/or change one or more treatmentparameters (e.g. energy spot size, energy spot shape, duration of thetreatment, output of the energy, direction of the movement of the energyspot and/or scanning speed) in order to bring the temperature of thetreated tissue back to within tolerance of the set target value and/orwithin the threshold range.

In another example, the set threshold value may be the distance of thetreated tissue from scanning unit or handheld applicator. Because thepresence of unevenness on the treated tissue may bring the scanning unitand/or handheld applicator closer to the treated tissue, the controllermay respond by adjusting the distance in order to keep the actualdistance as close as possible to the set threshold value. In alternateembodiments, the controller may emit a human perceptible signal, ceasethe treatment and/or change one or more treatment parameters (e.g.output of the energy and/or energy spot size) in order to compensate forthe change in distance. Changing one or more treatment parameters maylead to a change in a threshold value. Changing one or more treatmentparameters according to the distance of the treated tissue from scanningunit or handheld applicator may be advantageous for treatment of lessapproachable curved parts of the body (e.g. flanks, legs and/or hips).

In still another example, two threshold values representing thetemperature of the treated tissue during the treatment and distancebetween the tissue and scanning unit or handheld applicator may be set.When the temperature of treated tissue and the distance are differentfrom the set threshold values (e.g. because of the tissue is uneven orthe light source is non-homogenous), responses may include ceasingoperation, emitting a human perceptible signal, changing one or moretreatment parameters (e.g., the output of the energy, the energy spotsize, the scanning speed, the direction of movement of the energy spot,the treatment pattern, the wavelength or wavelengths of the energy, thefrequency and/or the energy flux) in order to bring the measuredparameters of the treated tissue closer to the set threshold valuesand/or into the tolerance provided by threshold ranges.

Response to a measured characteristic of the tissue problem may includeceasing treatment and/or changing treatment parameters. For example, aresponse may include decreasing the scanning speed, changing thetreatment pattern, and/or repeated movement of the energy spot over thetissue problem when the tissue problem retains the color duringtreatment. In another example when the energy spot is moved to adifferently colored part of tissue problem (e.g. a tattoo), thewavelength of the applied light may be changed, for example to provide adifferent treatment to differently-colored pigment and/or ink. In stillanother example, a response may include changing the power output,energy spot size, wavelength of the energy and/or the distance betweenthe tissue and the scanning unit when at least part of the tissueproblem is located deeper than anticipated during initial mapping of thetissue problem. In still another example, a response may includechanging the treatment pattern together with changing the wavelength ofthe applied light. In such cases, when the color of the already-treatedtissue problem changes during and/or after the treatment, the energyspot may be repeatedly moved over the tissue problem, while the appliedlight has different wavelengths matching the different color of thetissue problem.

Response to changes or lack of changes in shape of the tissue problemmay include ceasing treatment and/or changing one or more treatmentparameters. For example, when the shape of the tissue problem changes,the treatment parameter and/or energy spot size may be changed in orderto match new shape of the tissue problem. In other embodiments, theoutput power of the energy and/or scanning speed may be changed.

Methods of treatment may further include ceasing operation of the deviceand/or emitting a human perceptible signal according to the informationfrom and ultrasound sensor and/or a gyroscope if an error occurs. Errorsdetected may include, but are not limited to, movement of the patientsensed by ultrasonic sensor, a change in the distance between thescanning unit and the tissue, or movement of the scanning unit itselfsensed by a gyroscope or accelerometer. An ultrasonic sensor and/or agyroscope may then provide such information to a controller. Thecontroller may process the information and cease the operation of deviceand/or emit a human perceptible signal (e.g. sound, change of scanningcolor).

Other sensors 1013 may comprise a sensor measuring oxygenation of theblood. An oxygenation sensor may be of a contact type, or preferably anoncontact type. Examples of oxygenation sensors include, but are notlimited to, a Clark electrode, an RGB camera, a spectrophotometer, orone or more CCD cameras with specific filters (e.g. 520 nm and/or 660nm). In some embodiments, oxygenation sensors of the present inventionprovide information about blood flow and healing of the tissue.Oxygenation of the tissue may also be measured by a diffuse correlationspectroscopy flow-oximeter. Methods may include measurement ofoxygenation of the blood in blood vessels in and/or close to thetreatment area. Oxygenation of the blood may be measured in bloodvessels in and/or close to the treatment pattern. Oxygenation sensorsmay provide information to the central control unit 1004. The centralcontrol unit 1004 may include a proportional controller which may ceasethe transfer of energy when the blood oxygen level drops below anoxygenation limit having a value of 98%, more preferably 96.5%, mostpreferably 95%. In some embodiments, the central control unit 1004 mayinclude a PD and/or a PID controller which may adjust one or moretreatment parameters. In some embodiments, when the blood oxygen leveldrops below a limit, possible responses include ceasing operation,decreasing and/or increasing output power, changing the wavelength ofthe energy and/or changing the energy generator. Power output may bedecreased in order to decrease tissue temperature and/or the level oftissue damage (for example ablation or coagulation). Changes towavelength may include changing the wavelength to one of or close to redlight, which may enhance blood oxygenation. Changes of the energygenerator may include changes to the energy generator (e.g. red light)which may enhance blood oxygenation. In some embodiments, the responsemay include changes to one or more other treatment parameters.

The scanning unit may move over the tissue and stop in one or morepredefined and/or random positions. Treatment durations may be in therange of 5 seconds to 90 minutes, more preferably in the range of 10seconds to 75 minutes, most preferably in the range of 30 seconds to 60minutes. The distance of the scanning unit from the tissue may be in therange of 0.5 cm to 100 cm, 1 cm to 80 cm or 3 cm to 65 cm. Scanningspeed, defined as the distance traversed by the scanner in a given unitof time, may be in the range of 0.01 cm/s to 150 cm/s, more preferablyin the range of 0.05 cm/s to 100 cm/s, most preferably in the range of0.1 cm/s to 80 cm/s.

Applied energy may be electromagnetic energy, e.g. gamma radiation,X-rays, UV energy, light, IR energy, radiofrequency energy and/ormicrowave energy. Light may be coherent, depolarized, polarized,monochromatic or polychromatic. The wavelength of the light may be inthe range of 200 nm to 15,000 nm, more preferably in the range of 250 nmto 1,0000 nm, even more preferably in the range of 300 nm to 5,000 nm,most preferably in the range of 400 nm to 3000 nm.

Light may be also applied in a narrower spectral band. In someembodiments, light is applied in spectral bands representing differentcolors of the visible part of the electromagnetic spectrum. Thewavelength of the applied light may be close to 254 nm, 405 nm, 450 nm,532 nm, 560 nm, 575 nm, 635 nm, 660 nm, 685 nm, 808 nm, 830 nm, 880 nm,915 nm, 970 nm, 980 nm, 10060 nm, 10064 nm, 1320 nm, 1440 nm 1470 nm,1540 nm, 1550 nm, 1565 nm, 2940 nm, 11600 nm. Term “close to” refers toa range within 20%, more preferably 15%, most preferably 10% of thenominal wavelength. In some embodiments, light in the range of 620 to750 nm is used for local circulation enhancement and restoration ofconnective tissue. Light in the range of 400 to 500 nm may be used tokill bacteria; light in the range of 560 to 600 nm may be used tostimulate tissue rejuvenation. In some embodiments, the wavelength maybe changed during treatment. Methods of treatment may includeapplication of a targeting beam of any visible (e.g. red, blue, green orviolet) color.

Light may be applied in one or more beams. One beam may include light ofmore than one wavelength, e.g. when the light is provided by sources ofdifferent color and intensity One beam may provide an energy spot havingan energy spot size defined as a surface of tissue irradiated by onebeam of light. One light source may provide one or more energy spotse.g. by splitting one beam into a plurality of beams. The energy spotsize may be in the range of 0.001 cm² to 600 cm², more preferably in therange of 0.005 cm² to 300 cm², most preferably in the range of 0.01 cm²to 100 cm². Energy spots of different and/or the same wavelength may beoverlaid or may be separated. Two or more beams of light may be appliedto the same spot in the same time or with a time gap ranging from 0.1 usto 30 seconds. Energy spots may be separated by at least 1% of theirdiameter, and in some embodiments energy spots closely follow each otherand/or are separated by a gap ranging from 0.1 cm to 20 cm. Energy spotsof the present invention may have any shape, e.g. a circular shape. Inapplication methods using more than one energy beam, the controller maycontrol the treatment parameters of each energy beam independently.

Light energy output may be up to 300, 250, 150 or 100 W. Light may beapplied in a continuous manner or in pulses having a duration in therange of 10 μs to 5 seconds, more preferably in the range of 25 μs to 4seconds, most preferably in the range of 40 μs to 2.5 seconds. Inaddition, pulses may have a duration in the range of 1 fs to 10 μs.Pulse frequency may be in the range of 0.2 Hz to 100 kHz, morepreferably in the range of 0.25 Hz to 40 kHz, most preferably in therange of 0.4 Hz to 25 kHz. Energy flux provided by light may be in therange of 0.005 W·cm⁻² to 75 W·cm⁻², more preferably in the range of 0.01W·cm⁻² to 60 W·cm⁻², and most preferably in the range of 0.01 W·cm⁻² to50 W·cm⁻².

Applied light may be low level light. Output power may be in the rangeof 0.1 mW to 600 mW, more preferably in the range of 1 mW to 500 mW,even more preferably in the range of 1.5 mW to 475 mW, most preferablyin the range of 3 mW to 450 mW.

Applied light may be high level light. In this case, the output of thesource may be in the range of 0.1 W to 300 W, more preferably in therange of 0.2 W to 75 W, most preferably in the range of 0.35 W to 60 W.

The energy output of light over time may have triangular waveform shownin the FIGS. 15A-C. As shown on the FIG. 15A, each triangular wave mayfollow closely after the previous one. Alternatively, as shown in FIG.15B, the triangular waves may be separated from one another by intervals1501 of the same and/or different lengths. In some embodiments, thewaveforms comprise multiple small steps of increasing and decreasingoutput, wherein the steps resemble a triangular shape, as shown on FIG.6C.

Methods of treatment may include autonomous treatment provided by thedevice, including the steps of choosing the body part to be treated;mapping the tissue problem with the sensor; initializing andautomatically modifying the shapes and dimensions of one or moretreatment areas; selecting the shapes and dimensions of one or moretreatment patterns; setting threshold values of treatment parameters;setting threshold ranges of one or more sensed parameters; choosing thetreatment mode; transferring energy to the tissue; measuring thetreatment parameters and/or characteristics of the tissue problems (e.g.color, shape and/or depth); and responding to measurement.

Methods of treatment may include autonomous treatment methods. Whenautonomous treatment is provided, almost all steps of the treatment aredirected by the device. Either the operator or the patient may choosethe part of the body to be treated. All other steps includinginitializing and automatically modifying the shape and dimensions of theone or more treatment areas, selecting the shape and dimensions of oneor more treatment patterns, setting threshold values of treatmentparameters, setting the threshold ranges, transferring energy to thetissue, measuring treatment parameters and/or characteristics of tissueproblems, and/or responding to measurement, may be performedautonomously by the device, where the method may include correctionand/or modification of the operation of the device by the device itselfaccording to the measured information from the sensors. During theautonomous treatment methods, the adjustable arm may be operatedautomatically according to treatment program.

Methods of treatment may include semiautonomous treatment. When asemiautonomous treatment is provided, the device may provide autonomoustreatment with possible correction and/or modification of its operationby the operator and/or patient during the treatment. The correctionand/or modification of the operation may be performed according to themeasured information from the sensors, the patient's needs and/or theoperator's needs. During the autonomous treatment methods, theadjustable arm may be operated automatically according to correctionsand/or modification provided by the operator. Method of treatment mayinclude application of light providing a fractional treatment generatingthermally damaged tissue. Thermal damage may be ablative or non-ablative(e.g. coagulation). Thermally damaged tissue may be located at least inone of the epidermis, dermis and/or hypodermis. Fractional treatment maygenerate thermally damaged tissue with channels, wherein channels may beopened in epidermis and reach into epidermis, dermis and/or hypodermis.Alternatively, thermally damaged tissue may be located only in one ormore skin layers, but without opening channels in epidermis. Regions ofthermally damaged tissue may be separated by untreated tissue.

Methods of treatment may include application of two or more wavelengthsof light. Two or more wavelength may be generated by one energygenerator, e.g. by differently stimulated optical fibre). Two or morewavelengths may be generated by two or more energy generators, Methodsof treatment may include application of time-shifted light (e.g. asecond laser). The scanning unit 1002 and/or handheld applicator 1014may include a crystal located in the propagation path of the secondlaser beam, which may cause a time-shift of light propagation. Thetime-shifted laser light may be transmitted later than the first laserlight. Therefore both lasers, particularly in pulse mode, may treat thesame energy spot (i.e. the surface of the tissue irradiated by theenergy spot). Such an arrangement may be used for providing improvedhealing and/or rejuvenation to treated tissue. Similarly, more than oneenergy beam may be used for removal of color irregularity, ablation oftissue and/or skin tightening. The second light with a differentwavelength may provide a healing effect.

In one embodiment, a combination of first and second light may providefractional treatment and non-ablative fractional treatment. The firstlight providing fractional treatment may have wavelength in the range ofabout 1300 nm to about 1600 nm or about 1440 nm to 1550 nm.Alternatively, the first light may have wavelength in the range of about2700 nm to 3100 nm or about 2900 nm to 3000 nm. The second lightproviding wound healing stimulation may have wavelength in the range of600 nm to 1,200 nm. Alternatively, the second light may have wavelengthin the range of about 1,000 nm to 1,200 nm. When the first light isapplied before the second light, the tissue is firstly ablated and thenthe healing of thermally damaged tissue is stimulated. When the firstlight and the second light are applied simultaneously, the tissue isablated in the same time as the healing of thermally damaged tissue isstimulated.

In another embodiment, a combination of first and second light mayprovide ablative fractional treatment and coagulation. The first lightproviding ablative fractional treatment may have wavelength in the rangeof about 2700 nm to about 3100 nm or about 2900 nm to 3000 nm. Thesecond light providing coagulation may have wavelength in the range ofabout 1300 nm to about 1600 nm or about 1440 nm to 1550 nm. When thefirst light is applied before the second light, the tissue is firstlyablated and then the thermally damaged tissue or/the untreated tissuemay be further coagulated to enhance the treatment effect. When thefirst light and the second light are applied simultaneously, the tissueis ablated and coagulated in the same time. When the second light isapplied before the first light, the ablation of the tissue by the firstlight may last shorter time than coagulation itself, eliminating pain orinconvenience.

In another embodiment, a combination of first and second light mayprovide fractional treatment and pain relief. The first light providingfractional treatment may have wavelength in the range of about 1300 nmto about 1600 nm or about 1440 nm to 1550 nm. Alternatively, the firstlight may have wavelength in the range of about 2700 nm to 3100 nm orabout 2900 nm to 3000 nm. Second light providing pain relief may havewavelength in the range of about 1,000 nm to about 1,200 nm or about1040 nm to 1080 nm. When the first light is applied before the secondlight, the tissue is firstly ablated and then the pain of the fractionaltreatment is eliminated. When the first light and the second light areapplied simultaneously, the tissue is ablated and the pain of thetreatment is eliminated in the same time.

Methods of treatment may also include application of a negative pressurebefore, during and/or after treatment by the energy. An exemplaryhandheld applicator capable of providing negative pressure is shown inFIG. 16A, where the handheld applicator may include one or more cavities1601 formed by walls 1107. Walls 1107 may form a vacuum edge or vacuumcup defining magnitude of patient's skin protrusion, pressure valueneeded for attaching applicator to patient's body and other properties.Vacuum mask may have a circular, rectangular or other symmetrical orasymmetrical shape. The tissue 1602 may be sucked into the cavity 1601by negative pressure generated by a source of negative pressure (notshown). Suitable sources of negative pressure include a vacuum pumplocated inside the device and/or external to the device but fluidlyconnected to cavity 1601. Negative pressure may create a skin protrusionwhich may move the tissue closer to the lens 1110. Negative pressure mayalso provide an analgesic effect. The negative pressure may be lower toroom pressure in the range of 100 Pa to 2 MPa, 3000 Pa to 400 kPa, or4000 to 100 kPa. Deflection of the tissue caused by negative pressuremay be in the range of 0.2 mm to 8 mm or 0.5 mm to 60 mm or 1 mm to 50mm or 1.5 mm to 35 mm. Pressure value under the applicator may bechanged compared to pressure in the room during the treatment in rangefrom 0.1 to 100 kPa or from 0.2 kPa to 70 kPa or from 0.5 kPa to 20 kPaor from 1 kPa to 10 kPa or from 2 kPa to 8 kPa. The negative pressuremay be pulsed and/or continuous. Continuous pressure means that thepressure amplitude is continually maintained after reaching the desirednegative pressure. Pulsed pressure means that the pressure amplitudevaries, for example according to a predetermined pattern, during thetherapy. Use of pulsed pressure may decrease inconvenience related tonegative pressure by repeating pulses of tissue protrusions at onetreated site, when the energy may be applied. The duration of onepressure pulse may be in the range of 0.1 seconds to 1,200 seconds, morepreferably in the range of 0.1 seconds to 60 seconds, most preferably inthe range of 0.1 seconds to 10 seconds wherein the pulse duration ismeasured between the beginnings of successive increases or decreases ofnegative pressure values. In case of using pulsed pressure the ratio ofPh/PI where Ph is value of highest pressure value a PI is lowestpressure value during one cycle of repeated pressure alteration may bein range from 1.1 to 30 or from 1.1 to 10 or from 1.1 to 5.

An exemplary apparatus including the scanning unit 1002 is shown in FIG.16B. Handheld applicator 1014 is connected to the scanning unit 1002includes scanning optics 1011. Tissue 1602 is shown to be sucked intocavity 1601 formed by walls 1107. Walls 1107 may form a vacuum mask orvacuum cup defining magnitude of patient's skin protrusion, pressurevalue needed for attaching applicator to patient's body and otherproperties. Vacuum edge may have a circular, rectangular or othersymmetrical or asymmetrical shape.

The scanning unit 1002, particularly the output of the scanning optics1011 may be located inside the cavity 1601 and/or outside of the cavity1601. When the output of the scanning optics 1011 is located inside thecavity 1601, the scanning unit may be stationary in respect to thetissue. Alternatively, the scanning unit may be mobile in respect to thetissue in all dimensional axis by coupling to manually or automaticallyadjustable arm. When the output of the scanning optics 1011 is outsidethe cavity 1601, the walls 1107 may be manufactured from transparentmaterial allowing the transfer of the light energy.

Vacuum edge may be manufactured from dielectric material, which may berigid, at least partly shape adaptive and/or at least partly elastic.Dielectric material from at least partly shape adaptive material mayprovide flexibility to adapt applicator surface to patient's surface andimprove contact of the dielectric material with electrode and/or thepatient body. Shape adaptive material(s) may also improve energytransfer from scanning unit and/or handheld applicator to patient'stissue.

Stiffness of the dielectric material may be in range shore A5 to shoreD80 or shore A5 to shore A80 or shore A10 to shore A50 or shore A10 toshore A30. Dielectric material may be made of different polymericcharacterization. Vacuum mask may cover the area in the range from 1 cm²to 32,400 cm², 15,000 cm², 10,000 cm² or 2,500 cm². Vacuum mask maycover at least part or whole abdomen, love handle, thighs, arm. Vacuummask may also cover whole torso of body.

Negative pressure or vacuum (lower air pressure than is air pressure inthe room) may be used for attaching of the applicator to a certainpatient's body part, may regulate contact area size of dielectricmaterial under the treatment energy source with the patient's surface,may provide massage of the patient's soft tissue, may help to reducecreation of hot spots and edge effect, may increase body liquidscirculation and/or different protrusion shapes

Methods of treatment may also include application of a mechanical energybefore, during and/or after treatment by the light energy. Mechanicalstimulation may be represented by ultrasound energy. Ultrasound energymay provide focused and/or unfocused heating, cavitation, microbubblesformation, muscle stimulation, stimulation of healing process, bloodflow stimulation and/or stimulation of inflammatory response. Thefrequency of the ultrasound energy may be in the range of 20 kHz to 25GHz, more preferably in the range of 20 kHz to 1 GHz, even morepreferably in the range from 50 kHz to 250 MHz, most preferably in therange of 100 kHz to 100 MHz. Energy flux provided ultrasound energy maybe in the range of 0.001 W·cm⁻² to 500 W·cm⁻², more preferably in therange of 0.005 W·cm⁻² to 350 W·cm⁻², most preferably in the range of0.05 W·cm⁻² to 250 W·cm⁻².

Mechanical stimulation may be represented by shock wave energy providingpain relief, blood flow enhancement, myorelaxation and/or mechanicalstimulation. Shock wave energy may be generated by electrohydraulic,piezoelectric, electromagnetic, pneumatic and/or ballistic generatorlocated internally or externally to the applicator. The repetition rateof shock wave energy may be in the range of 0.1 Hz to 1,000 Hz, morepreferably in the range of 0.1 Hz to 750 Hz, even more preferably in therange of 0.5 Hz to 600 Hz most preferably in the range of 1 Hz to 500Hz. Energy flux provided by shock wave energy may be in the rangebetween 0.0001 W·cm⁻² and 50 W·cm⁻², more preferably in the rangebetween 0.0001 W·cm−2 and 35 W·cm−2, most preferably in the rangebetween 0.0001 W·cm⁻² and 25 W·cm⁻².

In one embodiment ballistic shock waves may be used. Ballistic shockwaves may be generated by striking of a projectile inside a guiding tubeto a percussion guide, The projectile may be accelerated by pressurizedgas, spring, electric field, magnetic field or other technique. Therepetition rate of the ballistic shock wave may be in the range of 0.1Hz to 150 Hz or 0.5 Hz to 100 Hz or 1 Hz to 60 Hz.

In another embodiment ultrasound shock waves may be used. Ultrasoundshock waves may be generated by one or more piezoelements. At leastonepieolement may have a volume in a range of 1.5 cm³ to 160 cm³ or 1.5cm³ to 60 cm³ or 3.5 cm³ to 35 cm³ or 3.5 cm³ to 20 cm³. The diameter ofthe piezoelement may be in a range from 1 cm to 20 cm or 2 to 15 cm or 6cm to 10 cm. The frequency of the provided ultrasound shock waves may bein a range from 1 Hz to 25 Hz or 2 Hz to 20 Hz or 2 Hz to 15 Hz or 4 Hzto 14 Hz. The duration of one ultrasound shock wave pulse may be in arange of 200 ns to 4 us to 2.5 us or 800 ns to 1.5 us. The pulse widthof a ultrasound shock wave pulse positive phase may be in a range of 05us to 3 us or 0.7 us to 2 us or 0.8 us to 1.7 us.

Methods of treatment also include application of a radiofrequency energybefore, during and/or after treatment by the light energy.Radiofrequency energy may heat the adipose tissue and/or hypodermistissue, while the light may be used for treatment of dermis and/orepidermis. Radiofrequency energy may be transmitted into the tissuewithout physical contact with the patient, same as light. Contactlessapplication enables simultaneous treatments of large areas of humanbody. In the present contactless methods, the skin may be sufficientlycooled passively by circulating air.

Radiofrequency energy may be provided to the skin by at least onecapacitive electrode generating an electromagnetic field. Electrodepolarity may continuously fluctuate and induce an electromagnetic fieldinside tissue. Selective treating in the skin occurs due to dielectriclosses. An inductive electrode may alternatively be used. The treatmentsystem for creating the electromagnetic field can use bipolarelectrodes, where electrodes alternate between active and returnfunction and where the thermal gradient beneath electrodes is duringtreatment almost the same. The system may alternatively use monopolarelectrodes, where the return electrode has sufficiently large area incontact with skin of patient and is typically positioned a relativelarger distance from the active electrode. A unipolar electrode may alsooptionally be used.

The radiofrequency energy may be applied in continuous or pulse mode.Using a pulse mode of radio frequency treatment, the treatment is localand the power is typically limited to about 1,000 W. With the pulsemode, a high frequency field is applied in short intervals (typically inthe range of 50 μs to 500 ms) and on various pulse frequencies(typically in the range of 50 to 1,500 Hz). The maximum output duringthe continuous method is typically limited to 400 W. The frequency ofradiofrequency energy generated by (HF) generator may be in the range of10 kHz to 300 GHz, more preferably in the range of 300 kHz to 10 GHz,most 20 preferably in the range of 400 kHz to 6 GHz. In anotherembodiment, the radiofrequency energy may be in the range of 100 kHz to550 MHz, more preferably in the range of 250 kHz to 500 MHz, even morepreferably in the range of 350 kHz to 100 MHz, most preferably in therange of 500 kHz to 80 MHz. The frequency of radiofrequency energy maybe at 13.56 or 40.68 or 27.12 MHz or 2.45 GHz. The HF generator mayinclude balun transformer. The HF energy generator may include or becoupled to transmatch to adjust the input impedance to the impedance ofthe treated tissue in order to maximize the power transfer. Thetemperature of treated tissue may be increased to 37-69° C., morepreferably to 37-59° C., most preferably to 37-49° C. by radiofrequencyenergy.

An air gap or material with high air permeability may be placed betweenthe skin and the applicator. This arrangement uses the humanthermoregulatory system for cooling and avoids the need of artificialcooling of the skin. Optionally, the skin may be cooled via a stream ofchilled or ambient temperature air. The human thermoregulatory systemenables perspiration and other bodily fluids to evaporate and cool thesurrounding skin. The application of electromagnetic waves iscontactless, therefore sweat accumulation and/or hot spot creation areavoided. Cooling of the patient's skin may optionally use airflowcirculation using a stream of cooled or ambient temperature air. Coolingcan be provided by positioning an air moving device proximate to theskin. The air moving device may be attached to or implemented into theapplicator. Air moving device may be any kind of fan, ventilator orblower. The blower may include an air tube connected to air source formoving air through the air tube to the patient's skin. The air sourcemay alternatively be cooled to provide cooled air. Alternatively, airsuction may be also used as an active cooling method.

The sum of energy flux density of the radio frequency waves and theoptical waves applied to the patient during therapy, where the therapymeans simultaneous, successive or overlap treatment or treatments maylast up to 120 minutes, more preferably up to 60 minutes, mostpreferably up to 30 minutes, is in the range of 0.0025 W·cm⁻² and 120W·cm⁻², more preferably in the range of 0.005 W·cm⁻² and 90 W·cm⁻², mostpreferably in the range of 0.01 W·cm⁻² and 60 W·cm⁻². The energy fluxdensity of optical waves constitutes at least 1%, more preferably atleast 3% and most preferably at least 5% of the sum of energy fluxdensity.

Methods of treatment may include cooling of the treated and/or untreatedtissue before, during and/or after the treatment by the light energy.Cooling of tissue may protect the tissue from damage of epitheliallayer, overheating, burning of tissue or painful treatment. Cooling ofhypodermis may provide disruption of adipose tissue. Cooling of dermisor hypodermis may also provide decrease in blood circulationcontributing to slower heat dissipation of light energy. Cooling may beprovided by cooling element. Cooling element may include a coolantreservoir, an active solid cooling element and/or a cooled element. Thecoolant reservoir may include coolant, which may be sprayed onto and/orinto tissue and/or used to cooling the cooled element. Coolant mayinclude saline, glycerol, water, alcohol, water/alcohol mixture, coldair and/or liquid nitrogen. The temperature of the coolant may be in therange of −200° C. to 37° C. The cooled element may include thermalconductive material e.g. glass, gel, ice slurry and/or metal. The activesolid cooling element may include an Peltier element including activeside cooling the tissue and passive side which may be cooled by liquid(e.g. water), gas coolant (e.g. air), coolant and/or another Peltierelement. The temperature of the cooling element during the activetreatment may be in the range of −80° C. to 37° C. or −70° C. to 37° C.or −60° C. to 35° C. The temperature of the tissue may be decreasedunder the 37° C. The temperature of the tissue may be decreased in therange of −30° C. to 35° C. The tissue may stay cooled for time intervalof at least 1, 5, 30 or 60 minutes.

In one embodiment, the temperature of treated adipose tissue during onecooling cycle may be in the range of −10° C. to 37° C. or −5° C. to 20°C. or −3° C. to 15° C. while the temperature of dermis and/or epidermisis maintained in the temperature range of −5° C. to 15° or around thetemperature of about 0° C. In another embodiment, the temperature oftreated collagen tissue during one cooling cycle may be in the range of−80° C. to 37° C. or −75° C. to 20° C. or −70° C. to 15° C. while thetemperature of dermis and/or epidermis is maintained in the temperaturerange of −5° C. to 15° or around the temperature of about 0° C. Theforegoing description of preferred embodiments has been presented forpurposes of illustration and description. It is not intended to beexhaustive or to limit the invention to the precise form disclosed.Modification and variations are possible in light of the above teachingsor may be acquired from practice of the invention. All mentionedembodiments may be combined. The embodiments described explain theprinciples of the invention and its practical application to enable oneskilled in the art to utilize the invention. Various modifications asare suited to a particular use are contemplated. It is intended that thescope of the invention be defined by the claims appended hereto andtheir equivalents.

The invention claimed is:
 1. A method of a soft tissue treatment of apatient comprising: placing an applicator adjacent to a surface of abody part of a patient, the applicator including at least one electrode;providing a fastening mechanism fixing the applicator in contact withthe body part; providing a radiofrequency energy by the at least oneelectrode causing a heating of the soft tissue; providing an electriccurrent to the soft tissue by the at least one electrode causing amuscle contraction; and controlling the heating of the soft tissue bythe radiofrequency energy and parameters of the electric currentprovided by the at least one electrode via a control unit; wherein anenergy flux density of the radiofrequency energy is in a range of 0.01mW·mm⁻² to 10 W·mm⁻² and a frequency of the radiofrequency energy is ina range of 0.1 MHz to 25 GHz; and wherein the body part comprises a faceor a chin.
 2. The method of claim 1, wherein the fastening mechanismcomprises a belt.
 3. The method of claim 1, wherein the fasteningmechanism comprises an adhesive layer, wherein the adhesive layer islocated at a contact side of the applicator and the adhesive layer isconfigured to attach one or more parts of the applicator to the bodypart.
 4. The method of claim 1, further including at least one sensorconfigured to monitor a temperature of the soft tissue, a temperature ofpart of a heat exchanger, a temperature of a system enclosure, atemperature of the applicator, a pressure under the applicator, a flowof the heat transmitter, an infrared radiated spectrum, a heat capacity,a voltage, the electric current, an impedance, a capacity or aconductivity of any part of a treatment device or the body part.
 5. Themethod of claim 4, wherein the control unit is configured toautomatically change at least one of a frequency, an output power, apulse duration of the at least one electrode or to automatically changea temperature of a contact part of an applicator with the body partbased on a reading from the at least one sensor.
 6. The method of claim1, wherein the at least one electrode is configured to sequentiallyswitch between providing the radiofrequency energy and providing theelectric current.
 7. The method of claim 1, wherein the at least oneelectrode is configured to simultaneously apply the radiofrequencyenergy and the electric current to the soft tissue of the body part. 8.The method of claim 1, wherein the applicator is configured to bestationary adjacent to the body part.
 9. The method of claim 1, whereinthe applicator is flexible and configured to curve according to thesurface of the body part.
 10. The method of claim 1, wherein the controlunit is configured to maintain a temperature of an epidermis of thepatient in a range between 37° C. to 50° C.
 11. The method of claim 1,wherein a frequency of the electric current is in a range of 0.1 Hz to200 Hz.
 12. The method of claim 1, wherein a repetition rate of theelectric current is in a range of 0.1 kHz to 1 kHz.
 13. The method ofclaim 1, wherein the electric current is an alternating electriccurrent.
 14. The method of claim 1, further comprising positioning aspacing object between the applicator and the surface of the body part.15. The method of claim 1, wherein the applicator further includes anactive surface; wherein the active surface is configured to improve atransfer of the radiofrequency energy or the electric current into thesoft tissue; and wherein the active surface is configured to improve thecontact of the applicator with the body part.
 16. A device forradiofrequency field treatment and electrotherapy of a body part of apatient comprising: a control unit; and an applicator comprising: atleast one electrode; and a fastening mechanism; wherein the at least oneelectrode is configured to provide a radiofrequency field having afrequency in a range of 0.1 MHz to 25 GHz and an energy flux density ina range of 0.01 mW·mm⁻² to 10,000 mW·mm⁻²; wherein the at least oneelectrode is configured to provide an electric current having afrequency in a range of 0.1 Hz to 200 Hz; wherein the applicator isconfigured to be attached to a surface of the body part by the fasteningmechanism; wherein the device is configured to apply the radiofrequencyfield to the body part to cause heating of a soft tissue of the bodypart and to apply the electric current to the body part to cause amuscle contraction; and wherein the body part is a face or a chin.
 17. Amethod of soft tissue treatment of a body part of a patient comprising:placing an applicator on a surface of the body part, the applicatorincluding a plurality of electrodes; providing a fastening mechanismfixing the applicator in contact with the body part; providing aradiofrequency energy to a soft tissue of the body part by a firstradiofrequency electrode from the plurality of electrodes causingheating of the soft tissue; applying an electric current to the softtissue by a first electrotherapy electrode from the plurality ofelectrodes causing a muscle contraction; controlling heating of the softtissue and parameters of the electric current provided by the pluralityof electrodes via a control unit; and switching on and off at least oneelectrode from the plurality of electrodes based on a treatment patternduring the treatment; wherein an energy flux of the radiofrequencyenergy is in a range of 0.01 mW·⁻² to 10 W·mm⁻²; and wherein the bodypart comprises a face or chin.
 18. The method of claim 17, wherein theelectric current has a frequency in a range of 0 Hz to 12 kHz.
 19. Themethod of claim 17, wherein the radiofrequency energy has a frequency ina range of 0.1 MHz to 25 GHz.
 20. The method of claim 17, wherein thefirst radiofrequency electrode is a first electrode from a pair ofbipolar radiofrequency electrodes.
 21. The method of claim 17, whereinthe first electrotherapy electrode is a first electrode from a pair ofbipolar electrotherapy electrodes.
 22. The device of claim 17, wherein atreatment pattern is preprogramed into the control unit.
 23. The methodof claim 17, wherein the treatment pattern is configured to simulate amovement of an applicator guided by an operator on the body party byswitching between on and off states of the plurality of electrodes ofthe applicator.
 24. The method of claim 17, wherein the treatmentpattern is configured to provide the radiofrequency energy and theelectric current simultaneously or sequentially.
 25. The method of claim17, wherein the radiofrequency energy and the electric current areprovided to a same or to different target areas of the body part. 26.The method of claim 17, wherein the body part further comprises a neck.27. The method of claim 17, further comprising applying a vacuum underthe applicator by at least one vacuum aperture; changing a pressurevalue under the applicator compared to pressure in a room during thetreatment in a range from 0.1 kPa to 100 kPa; and attaching theapplicator in contact to the body part with the vacuum; wherein the atleast one vacuum aperture is part of the fastening mechanism.
 28. Amethod of a soft tissue treatment of a patient comprising: placing anapplicator adjacent to a surface of a face or a chin of the patient,with the applicator including a plurality of electrodes; providing abelt fixing the applicator in contact with the face or the chin; heatingthe soft tissue of the face or the chin by a radiofrequency fieldprovided by a first group of electrodes from the plurality of electrodeswith a capacitive heating of the soft tissue between the electrodes fromthe first group of electrodes; applying an electric current to the softtissue of the face or the chin by a second group of electrodes from theplurality of electrodes causing a muscle contraction; controlling theheating of the soft tissue of the face or the chin by radiofrequency bythe first group of electrodes and parameters of electric currentprovided by the second group of electrodes from the plurality ofelectrodes by a control unit based on a treatment pattern; andsimulating the movement of the applicator on the face or the chin byswitching on and off at least one group of electrodes from the pluralityof electrodes based on the treatment pattern; wherein an energy fluxdensity of the radiofrequency field is in a range of 0.01 mW·mm⁻² to 10W·mm⁻² and a frequency of the radiofrequency field is in a range of 0.1MHz to 25 GHz.
 29. The method of claim 28, wherein the electric currentis an alternating current with a frequency in a range of 0.1 kHz to 1kHz.
 30. The method of claim 28, wherein the heating of the soft tissuevia the radiofrequency field and application of the electric current tothe soft tissue is combined to cause at least one of an anti-ageingeffect, a soft tissue relaxation, or a body shaping.